Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Quality Complaints - Lab

Live

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 6 months of Quality experience OR

Associate’s degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

Global Quality Compliance Undergrad Intern

Live

This could be your everyday

Let’s do this. Let’s change the world. During this program, you will be working closely with the quality compliance team to help prepare to prepare the global auditing processes for migration into a new electronic system. You will have the opportunity to immerse yourself in learning drug/combination product/medical device auditing regulations while helping to streamline and simplify processes.

• Assist in Gathering User Requirements
• Help to Develop Workflows
• Redline and Process Procedural Updates
• Establish Standardized Forms, Reports
• Help to Plan and Execute Workshops

Win

Here’s what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. The quality minded individual we seek is detail orientated with these qualifications:

Basic Qualifications

Amgen requires that all individuals applying for a grad internship or a co-op assignment at Amgen must meet the following criteria:

• 18 years or older
• Currently enrolled in a full-time Bachelor’s Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent
• Completion of one year of study from an accredited college or university prior to the internship commencing
• Enrolled in a full-time Bachelor’s degree program following the potential internship or co-op assignment with an accredited college or university
• Must not be employed at the time the internship starts
• Student must be located in the United States for the duration of the internship

Preferred Qualifications

• Degree concentration(s) in life sciences or engineering.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth in addition to their well-being:

The base pay range for this opportunity in the U.S. is $24.70 - $28.30.

• Build a network of colleagues that will endure and grow throughout your time with us and beyond.
• Bring your authentic self to the table and become the professional you’re inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
• Participate in executive and social networking events, as well as community volunteer projects.

Apply now

for an internship/co-op that defies imagination

If you feel like you're part of something bigger, it's because you are. Join us.

careers.amgen.com Please search for Keyword R-170795

#NBMBAA

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

Undergrad Intern – R&D Strategy & Operations

Live

This could be your everyday

Let’s do this. Let’s change the world. This internship will be approximately 12 weeks and includes both project-based and experiential learning. The intern will be an integral member of the R&D Strategy and Operations (RDSO) organization, which is focused on driving innovation beyond the molecule and applying digital strategies to simplify processes. The 3 functional areas within RDSO are:

• Portfolio, Strategy & Execution: Catalyzing innovative drug development through insights-driven decisions and strategic R&D portfolio management
• R&D Business Operations: Innovating excellence and navigating efficiency to manage R&D operational activities, including budget and contracting, suppliers, laboratories, and biospecimen and research compliance
• R&D Capability Center: Transforming and advancing digitization and contemporized learning as well as cultivating talent & culture for a people-centric and inclusive workforce

As a member of Amgen's RDSO Organization, your work will be highly collaborative across multiple functions and levels within Amgen, including for example, Research & Development, Corporate Affairs, Digital Technology & Innovation, Diversity, Inclusion & Belonging, and others. You will be uniquely responsible for one or more key projects that will advance RDSO’s mission, including the following:

• Developing a project charter to map out objectives and identify key stakeholders, timelines, and deliverables
• Leveraging your analytical, leadership, communication, and interpersonal skills to work in teams, identify problems, conduct research, develop recommendations through qualitative and quantitative analysis, and deliver final projects
• Presenting your deliverables/findings through various forums including an intern-wide poster session and a final readout to executive management
• You will also be engaged in learning activities, networking with colleagues across the company, and enjoying full access to Amgen’s Employee Resource Groups

This job description serves as a general outline for the responsibilities of an undergraduate intern in RDSO. The specific tasks and requirements may vary depending on the organization and its projects.

Win

Here’s what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. The collaborative individual we seek is hard-working with these qualifications:

Basic Qualifications

Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria:

• 18 years or older
• Currently enrolled in a full-time Bachelor’s Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent
• Completion of one year of study from an accredited college or university prior to the internship commencing
• Enrolled in a full-time Bachelor’s degree program following the potential internship or co-op assignment with an accredited college or university
• Must not be employed at the time the internship starts
• Student must be located in the United States for the duration of the internship OR co-op

Preferred Qualifications

• Pursuing a degree in Business, Finance, Management Sciences, Life Sciences, Engineering, Communications, Psychology, Human Resources, or a similar field
• Strong written and verbal communication skills
• Highly organized, with an ability to manage multiple tasks and deadlines.
• Enthusiastic, proactive, and a willingness to learn.
• Adaptability in navigating and effectively responding to ambiguity and evolving circumstances and priorities.
• Basic understanding of project management concepts is a plus.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth in addition to their well-being:

The base pay range for this opportunity in the U.S. is $24.70 - $28.30 per hour.

• Build a network of colleagues that will endure and grow throughout your time with us and beyond.
• Bring your authentic self to the table and become the professional you’re inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
• Participate in executive and social networking events, as well as community volunteer projects.

Apply now

for an internship/co-op that defies imagination

If you feel like you're part of something bigger, it's because you are. Join us.

careers.amgen.com Please search for Keyword R-183322

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Observational Research Manager - US Remote

Do you want an exciting position working with multiple teams to generate real world evidence supporting a wide variety of business needs? The increasing demand for real-world evidence (RWE) from regulatory and reimbursement authorities makes observational research a key component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with an industry-leading analytical capability that generates RWE to support business needs across a product’s lifecycle. CfOR scientists partner with internal team members and industry experts to design, conduct, interpret and publish observational research that informs decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines. CfOR studies include but are not limited to evidence generation regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, treatment cost and utilization patterns, and the safety and effectiveness of therapeutic interventions.

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will have responsibilities for research activities on product-facing teams in the therapeutic area of cardiovascular disease. A CfOR Manager is recognized as a strong scientific contributor and is a first or contributing author for papers in peer-reviewed journals, abstracts for scientific congresses or for internal reports that enhance the company’s mission.

Key Activities include:

• Manages descriptive epidemiologic studies to characterize the incidence/prevalence of disease in US, EU, Asia, and emerging market countries
• Manages research projects involving the analysis of multiple types of data including medical claims, electronic health records, and prospective observational cohort studies
• Provides safety research support across the life cycle of Amgen products, supports the development of risk management plans, and implements pharmacovigilance studies
• Conducts literature reviews and prepares research reports and scientific manuscripts
• Stays abreast of the latest developments in the field of observational research and drug development
• Promotes awareness, understanding, and use of observational research methods
• Communicates scientific information to a variety of audiences

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications:

Basic Qualifications:

Doctorate degree

Or

Master's degree and 3 years of scientific experience

Or

Bachelor's Degree and 5 years of scientific experience

Or

Associate’s degree and 10 years of scientific experience

Or

High school diploma / GED & 12 years of scientific experience

Preferred Qualifications:

• Doctorate in Epidemiology or other subject with high observational research content
• Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting
• Experience in research to support drug development
• Experience working with secondary data systems, including administrative claims, EMR, registries
• Experience in observational research project planning and management
• Excellent verbal and writing communication and interpersonal skills
• Experience working in multi-disciplinary teams

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Process Development Associate Scientist

Live

What you will do

Let’s do this! Let’s change the world!

This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and biological characterization assays and supporting sample testing and regulatory submissions.

Responsibilities include:

• Implementing state-of-the-art and fit-for-purpose analytical potency methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations

• Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions

• Generating and analyzing analytical data to support: product development investigations, and regulatory submissions

• May contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation. Keeps current in analytical development field including literature and technology development. Supports analytical projects involving method development, qualification, and transfer

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

Master’s degree and 1 year of scientific experience, OR

Bachelor’s degree and 3 years of scientific experience

Preferred Qualifications:

• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins

• Expertise in cell-based bioassay development (characterization methods, qualification, validation, technical transfer)

• Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines

• Innovation – supports new ideas and initiatives

• Detail oriented and excellent documentation skills

• Experience with automated liquid handling preferred

• Client orientation– establishes effective and responsive relationships with all clients; ensures value is delivered

• Communication and Interpersonal skills – communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Engineer Drug Product Fill and Finish

Live

What you will do

Let’s do this. Let’s change the world. In this role the Sr Engineer is responsible for planning, design, construction, operations, maintenance, and technical support of Amgen manufacturing infrastructure, world-wide. The Engineering Technical Authority (TA) is responsible for technical direction, leadership, guidance, and support for a specific array of process systems within an area of responsibility, such as Upstream Processes, Downstream Processes, Fill/Finish, CIP/SIP, Clean Utilities, Utilities, HVAC, Packaging, Devices, etc. Through their team(s) of global and site technical domain experts, the TA will bring to bear engineering expertise both in the company and industry to optimize the life cycle management of Amgen’s assets and is accountable for performance and reliability across multiple sites. This position is in the Process System Engineering team, the position is for Formulation and Filling Systems with responsibility for technical leadership to formulation, aseptic filling and lyophilization operations for the manufacture of biopharmaceuticals.

Planning: Working with clients, as appropriate (e.g., PD, Quality, Manufacturing), develop and specify engineering standards, specifications, equipment selection and design. Develop metrics to support procurement strategies for equipment, inventory management, spares, and preventative maintenance. Manage and track changes to specifications and standards, and system configuration. Support new technology’s introduction for Formulation, Lyophilization process, Filling and Packaging equipment’s.

Design: Ensure alignment to standards and good engineering practices. Lead design of new systems in support of projects and new technology deployment. Ensure designs optimize the total life cycle of the asset, from both a cost and effectiveness standpoint.

Construction: Use their TA network to provide engineering support during the construction process, including responses to RFIs, resolving complex technical issues and conflicts, supporting overall project objectives.

Commissioning: Ensure commissioning and qualification standards are developed and used. Use their network to provide engineering support to commissioning and qualification.

Operations: Support development of, or approve operation procedures for the safe, efficient, and effective operations of systems. Review performance data and make recommendations for improvement of system operations. Support NC/CAPA investigations related to equipment failures.

Maintenance: Support systems failure analysis, approve maintenance standards and techniques. Support and review reliability and failure data, and implement actions to improve effectiveness, and reliability of systems. Develop, evaluate, approve, and document system changes. Assist the sites in system trouble shooting and take action as necessary to prevent future occurrence throughout network.

Management: Lead their technical authority network. Makes use of expertise at the site and corporate levels for solving problems and deploying solutions across all sites. Identify and resolve issues and conflicts. Provide mentoring of other members in their network. Ensure technical decisions for assigned systems are optimized with those managed by other TAs. Remain current on innovative for systems for adoption of new techniques and technology within Amgen. Represent Amgen with outside firms, technical societies, and regulatory bodies.

This role involves travel up to 40% including overnight stays

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree & 2 years of Engineering experience

OR

Bachelor’s degree or & 4 years of Engineering experience

OR

Associate’s degree & 8 years of Engineering experience

Or

High school diploma / GED & 10 years of Engineering experience

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Supplier Management and Performance Analytics, Manager

Live

What you will do

Let’s do this. Let’s change the world. This vital role will support R&D Strategy and Operations in the R&D Business Operations team, where we address complex business problems with exceptional people, tools, and processes. Our team supports key initiatives, business operations strategy as well as tactical, expert support to ensure our Research & Development staff receive the goods and services they need. This includes analytical support for budget forecasting and managing our external service providers with a robust supplier oversight and governance program. You will be part of Amgen’s corporate mission of bringing medicines to patients with unmet medical needs every day.

In this key role as Manager, R&D Supplier Management and Performance Analytics (SMPA), you will be responsible for oversight of outsourced scientific services supporting Amgen Research and Development departments and driving quality from external third-party providers with the goal of maintaining a stable supply of healthy suppliers capable of supporting a spectrum of R&D activity. You will also be acting as an incredible portfolio manager supporting Merger & Acquisitions activities to facilitate the detailed integration of activities, help us exceed productivity goals and deliver against our operational goals, primarily supplier and expense management to ensure adherence to Amgen’s requirements (policies, procedures, and SOPs). You will ensure best practice project management, functional engagement and close partnership with the Global Strategic Sourcing, Finance, Source to Pay, R&D budget leads, Alliance Management as well as the R&D Budget and Supplier management network to enable the successful integration. Please join an outstanding team that delivers for our partners!

Day-to-day activities include project management skills including identifying new suppliers, driving supplier governance meetings, managing timelines, facilitating data collection, and reporting of KPIs/metrics, triaging issues, and assisting with forecasting to ensure our ability to support the pipeline. The individual will also serve as an internal escalation point capable of issue triage, elevate, and resolution.

Responsibilities:

• Develop and executing effective supplier management strategy for our R&D functions, mainly but not limited to Global Research

• Establish/optimize fit for purpose support model to ensure smooth execution of contracted results

• Support mergers and acquisitions cross-functional efforts, ensuring tasks are completed within specific timelines, communication and change management execution, and involved in cross-functional strategy.

• Develop strong collaborative relationships and display an ability to support a variety of cross-functional activities with internal partners to support and proactively respond to business needs.

• Act as subject matter authority in collaborating with the team to identify, develop and deploy best practices for procurement, category management and supplier performance management.

• Maintain oversight of a global pool of suppliers and find innovative solutions that provide the right mix of quality, agility, and value.

• Elevate the strategic values of supplier relationships by optimizing the mix, volume, and type of work packages.

• Implement fit for purpose portfolio and expense management strategies to support planning, tracking, and reporting.

• Lead supplier evaluation, qualification, & remediation teams

• Create and maintain Supplier Key Performance Indicators, monitor metrics, and raise issues as appropriate within Supplier Governance (fit for purpose) for supplier oversight and find innovative solutions to elevate strategic value of supplier relationships

• Ensure adherence to corporate sourcing and procurement guidelines; coordinate the contract to pay process for the assigned category

• Lead external spend strategy, and support the annual budget forecasting and latest estimate projections with the Global Medical functional leads

• Collaborate with the Budget Lead team and partners to develop/maintain budget visualization tools to ensure transparency of budget, calculate the budget/project forecast, and timelines

• Assist functional partners in defining external third-party provider Scope of Work (SOWs), leading the implementation of the agreed work packages, managing the supplier relationship, and resolving issues relating to contract negotiation or supplier service delivery.

• Assist Sr. Manager SMPA in optimizing and expanding the strategic values of SMPA support model to other function areas, identifying and evaluating other suppliers within the function area that should adopt the SMPA support model

• Develop, create, and transition any existing non-automated support model into an automated format

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manager we seek has these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of biotech/pharma-related business operations/supplier management experience

Or

Master’s degree and 4 years of biotech/pharma-related business operations/supplier management experience

Or

Bachelor’s degree and 6 years of biotech/pharma-related business operations/supplier management experience

Preferred Qualifications:

4+ years' experience in leading complex projects.

Expertise in the use of supplier and program management methodologies, and organizational change techniques

Understanding of discovery research and clinical development

Understanding of pharmaceutical industry landscape and business principles

Strong problem-solving skills and knowledge of analytical tools within MS Office, Smartsheet, Tableau, and other software programs

Extensive experience in Supplier Management and/or Alliance Management

MBA or business operations degree or equivalent experience in business/operations management

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Biostatistics Associate Director

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Associate Director Biostatistics independently leads sophisticated studies and projects in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary project teams. Specific duties include:

• Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
• Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs).
• Providing input for clinical publications and regulatory filing documents.
• Leading all aspects of work performed by study statisticians.
• Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations.
• Anticipating and communicating resource and quality challenges that could impact results or timelines.
• Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
• Contributing to process improvements and operational efficiencies.

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is an emerging leader with these qualifications.

Basic qualifications

• Doctorate degree and 2 years of experience OR Master’s degree and 6 years of experience OR Bachelor’s degree and 8 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience

PREFERRED QUALIFICATIONS

• Doctorate degree in biostatics or statistics.
• 7 or more years of pharma/biotech statistical experience.
• Life cycle drug development experience (pre-clinical, clinical and post-marketing).
• Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
• Strong verbal and written communication combined with organizational skills and cross- cultural sensitivity
• Statistical leadership and contribution to regulatory and reimbursement submissions.
• Strong working knowledge of theoretical and applied statistics and of regulatory guidelines.
• Prior experiences in metabolic disease area development

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Process Development Sr. Scientist - Analytical Chemist

Live

What you will do.

Let’s do this! Let’s change the world!

Amgen is currently seeking a Sr. Scientist - Analytical Chemist in our Pre-Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for early phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of early phase drug substances and drug products. The individual will work closely with a team of analysts and scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes in product and process for early phase synthetic programs. The Sr. Scientist will integrate and successfully use platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND filings. The Sr. Scientist should have strong analytical chemistry and communication skills.

Key Responsibilities:

• Analytical method development, validation and trouble-shooting for small molecule drug substances and drug products and in-process testing

• Define analytical control strategies and implement methodologies for development of early phase clinical programs.

• Collaborate with drug substance and drug product process development colleagues.

• Manage activities at contract manufacturing and testing sites.

• May lead and develop a small group of scientists.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree completed by time of hire OR

• Master’s degree and 4 years of scientific experience OR

• Bachelor’s degree and 6 years of scientific experience

Preferred Qualifications:

• PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering

• Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.

• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry.

• Experience in a wide variety of structure elucidation and physio-chemical techniques including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.

• Developing and implementing methods for in-process testing, release and stability testing.

• Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products.

• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, early phase development, etc.

• Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner

• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, handle deliverables against timelines

• Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile

• Works well in cross-functional teams, and across various geographic locations in different time zones

• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

• Experience with synthesis, method development and attribute characterization for small molecules, peptides or oligonucleotides

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Technical Product Owner-Electronic Lab Notebook (ELN)

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will function as the Technical Product Owner for ELN responsible for the strategic oversight and development of the Research ELN platform. You will play a crucial role in supporting lab processes aligned with Good Laboratory Practice (GLP) requirements, ensuring that the platform aligns with rigorous standards to maintain the integrity and reliability of research data. Additionally, the role involves collaborating with technical teams to optimize ELN data mining capabilities, thereby improving research insights and decision-making processes. The ELN Product Owner will also play a key role in defining the future state of ELN, blurring the lines with Preclinical Laboratory Information Management Systems (LIMS), and moving towards a versatile, cloud-based ecosystem to meet evolving research needs.

This role requires a unique blend of scientific knowledge and IT proficiency, enabling you to translate the needs of our research teams into effective digital solutions. You'll collaborate with cross-functional teams to ensure the ELN system meets current requirements and is scalable for future demands.

Key Responsibilities:

• Product Strategy and Vision: Define and communicate the vision for the ELN, ensuring it aligns with strategic goals and operational needs.

• Requirement Elicitation: Collaborate with Research scientists, IT specialists, and business partners to identify and analyze requirements for the ELN system.

• Roadmap Development: Create and maintain a product roadmap, prioritizing features and functionalities based on stakeholder input, strategic importance, and regulatory changes.

• Integration and Alignment: Manage integrations between the ELN and related systems, optimizing data flow and enhancing user experience across platforms.

• Project Management: Lead all aspects of the development lifecycle of the ELN, ensuring timely delivery of features and updates. Use Agile methodologies to manage development iterations and releases.

• Quality Assurance and Compliance: Ensure system compliance with Amgen standards and regulatory requirements, including data integrity and security.

• Training and Support: Develop comprehensive training programs for users and provide ongoing support and troubleshooting assistance.

• Vendor Management: Collaborate with software vendors and external consultants to ensure their services and products meet our requirements.

• Compliance and Security: Ensure that the ELN complies with Amgen’s standards and regulations. Be responsible for the security aspects of the software to protect sensitive research data.

• Feedback and Continuous Improvement: Implement feedback mechanisms to gather user input, using this data to continually refine and enhance systems.

• Budget Management: Manage the budget for assigned scope, ensuring cost-effective resource allocation.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of informatics and/or information systems experience

Or

Bachelor’s degree and 5 years of informatics and/or information systems experience

Or

Associate’s degree and 10 years of informatics and/or information systems experience

Or

High school diploma / GED and 12 years of informatics and/or information systems experience

Preferred Qualifications:

• BS or MS in life sciences, computer science or engineering.

• Experience as a product owner, project manager, or similar role in the pharmaceutical, biotech, or related industry.

• Strong knowledge of preclinical research processes and data management requirements.

• 3+ years of experience in implementing and supporting ELN (IDBS, Revvity, Benchling, Biovia, or similar product), LIMS and/or other scientific data management systems.

• Knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GMP).

• Experience handling GxP data and system validation.

• Strong understanding of Agile methodologies and project management tools.

• Experience with cloud technologies (e.g., AWS) and SaaS platforms.

• Familiarity with programming languages for managing data (e.g. SQL) and data analytics platforms (e.g. Spotfire, Tableau).

• Collaborative spirit and effective communication skills to interact effectively with both technical and non-technical collaborators.

• Problem-solving mentality and strong analytical skills.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Principal Scientist, Clinical Pharmacology, Modeling & Simulation

Live

What you will do

Let’s do this. Let’s change the world. The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Principal Scientist at its South San Francisco, CA location. In this vital role you will be responsible for the development and implementation of the Quantitative Clinical Pharmacology, Modeling and Simulation strategies for cutting-edge novel modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates, CAR-T cells-based therapies in addition to small molecule & mono-clonal antibodies.

The Principal Scientist will be Subject Matter Expert who will apply innovative Quantitative Clinical Pharmacology approaches to guide optimal drug development including Pharmacokinetic/Pharmacodynamic (PK/PD) modeling, Mechanistic-Physiologically Based Pharmacokinetic (M-PBPK) modeling, Mechanistic-PBPK-Pharmacodynamic (M-PBPK-PD) modeling and Quantitative Systems Pharmacology (QSP) modeling to ensure development of safe & effective dosing regimens for various patient sub-populations & also to ensure optimal drug development.

You will apply Model-Based Drug Development and principles of quantitative clinical pharmacology to ensure optimal drug development.

This position is based in Amgen, South San Francisco site and candidates that can be based at this site are preferred. Amgen also offers Flexible work models including working from home options and consideration can also be given to qualified remote candidates.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience

Or

Master’s degree and 5 years of Clinical Pharmacology and Modeling & Simulation experience

Or

Bachelor’s degree and 7 years of Clinical Pharmacology and Modeling & Simulation experience

Preferred Qualifications:

• PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering or equivalent professional degrees e.g. MD, PharmD).
• 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
• Hands-on experience in Quantitative Clinical Pharmacology approaches with a focus on PK/PD modeling, M-PBPK modeling, M-PBPK-PD modeling, and QSP modeling to inform clinical study designs, optimal dosage selection in target patient populations, characterization of drug-drug interactions, dosing in special populations, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PK/PD, M-PBPK, M-PBPK-PD, & QSP modeling required.
• Established track-record of Model Based Drug Development (MIDD).
• Established track-record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.
• Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Clinical Research Medical Director, Inflammation

Live

What you will do

Let’s do this. Let’s change the world. The Inflammation Therapeutic Area within Global Development is rapidly growing and in this vital role you will have an opportunity to shape this Therapeutic Area. This role will report directly to the Global Development Lead for a program. The position is US - Remote.

Responsibilities:

• Serve as clinical expert to provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan for the indication(s).

• Provide oversight of LCM clinical development with input on global strategy
• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)

• Participate and provide clinical input into safety and regulatory interactions

• Interpret and communicate clinical trial data

• Author/review CSRs, publications and regulatory submissions

  Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL

• Identify new clinical research opportunities

• Support in-licensing and out-licensing activities and partner relationships Support product lifecycle management for new indications as directed by Global Development Lead

• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization

• Approximate 10% travel may be require

• Potential managerial role, seeking and developing talent in past will be a plus

Knowledge:

• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

• In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials in all phases of development esp Ph2/3 registrational trials

• Medical knowledge in the relevant therapeutic area

• Sound scientific and clinical judgment

• Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups

• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

• Prior experience of regulatory interactions, authoring filing IND or BLA experience

• Understanding of new drug commercialization and business practices

• Understanding of resourcing and budgeting

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Medical professional we seek is a leader with these qualifications.

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

Preferred Qualifications:

• MD plus accredited residency in relevant sub-specialty, board certified or equivalent.
• Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
• Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
• Involved in filing activities as part of the moving the program through the development lifecycle.
• Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.
• Previous management experience of clinical development professionals

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $256,334. - $318,868.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Asset Lead Medical Director, Oncology Solid Tumor Pipeline, US-Remote

Live

What you will do

Let’s do this. Let’s change the world. In this vital role the Global Asset Lead Medical Director, Oncology Solid Tumor Pipeline will be accountable for development and execution of the global medical affairs strategy for one of Amgen's promising solid tumor pipeline assets. The Asset Lead Medical Director will also be accountable for Global Medical Affairs Team (GMAT) with the objective of maximizing Amgen’s value proposition.

Responsibilities:

• Lead the cross-functional and cross-regional development of the global medical affairs strategies for one of Amgen's pipeline asset through the GMAT
• Provide support for the development and execution of the clinical development plan
• Actively provide insights and support the development of the early Target Product Profile
• Coordinate with the regions to develop and lead the external stakeholder management plan, communication strategy, scientific platform, publication plan and evidence generation plans
• Develop robust external stakeholder engagement and insight gathering to strengthen understanding of the unmet need and maximize medical value of the asset
• Enhance Amgen’s reputation as a science-based and patient focused reliable partner
• Partner on evidence generation and ensure key regional/local needs are addressed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications.

Basic Qualifications:

MD/DO degree from an accredited medical school OR PhD OR PharmD

AND

2 years of Medical Affairs experience in Hematology-Oncology

Preferred Qualifications:

• MD plus accredited fellowship in Oncology, board certified or board eligible
• Clinical and disease knowledge base in solid tumor (specifically thoracic or I-O)
• 4+ years Hematology or Oncology Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
• 2+ years of clinical research experience and/or basic science combined with clinical teaching and patient care activities
• Familiarity with global regulatory organizations, guidelines, and practices
• Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $232,290. to $284,490.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr. Packaging Engineer

Live

What you will do

Let’s do this. Let’s change the world. In this role you will report into the Packaging Engineering group under Combination Product Operations (CPO) and is located in Thousand Oaks, CA. The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position will apply engineering principles to implement the accurate design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. A knowledge of common materials used in healthcare packaging is key to this role. Material knowledge of structural components are integral in the day-to-day oversight of this role: bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc. This role may have some junior level management potential and the successful candidate will also apply excellent organizational, project management, technical problem solving and communication (written and verbal) skills, with the ability to work in teams and adapt to a dynamic environment.

• Possible management of junior level engineers and contingent workers
• Lead testing and evaluations to recommend and select primary and secondary packaging materials for both large and small molecule products
• Perform distribution testing per ASTM D4169. Complete testing standards using ASTM, ISO, TAPPI, USP and EP
• Writing of test protocols, perform technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components
• Crafting specifications along with implementation through technical change records
• Build, modify, and approve engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications
• Assist in trouble shooting and leading investigations on Packaging Component problems for areas in production, warehouse, incoming inspection (minor and major deviation lead)
• Support line trials and packaging validation activities prior to introduction of any new or change in components/processes
• Collaborate with multi-functional teams (i.e. Manufacturing, Process Development, Quality, Supply Chain, Maintenance, Device Engineering, Primary Container Engineering, Artwork/Labeling, Regulatory, etc.) in pre-commercial and commercial activities
• Represent CPO and Manufacturing Sciences and Technology (MSAT) as Final Product Technical Lead
• Support Pre-Approval Inspections, Audits, and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree in Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field

OR

Master’s degree in Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 2years of Packaging Engineering experience

OR

Bachelor’s degree in Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 4 years of Packaging Engineering experience

OR

Associate’s degree in Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 8 years of Packaging Engineering experience

OR

High school diploma / GED & 10 years of Packaging Engineering experience

Preferred Qualifications:

• Bachelor’s degree in Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
• 7+ years of packaging engineering experience with 4+ years within the Pharma/Bio industry

Demonstrated Competencies/Skills:

• Familiar with distribution testing per ASTM D4169. Familiarity with ASTM, ISO, TAPPI, USP and EP testing standards.
• Knowledge of primary and secondary packaging systems and material science is critical to the position
• Strong organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to continuously evolving environment
• Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Independent problem solver with demonstrated skills working in teams or leading project teams

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range