Total 4 job vacancies by 1001 Amgen Inc.

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?

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.

SENIOR MANAGER, IN-VITRO DIAGNOSTICS/ PRECISION MEDICINE QUALITY

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will report to the Senior Director, In-Vitro Diagnostics (IVD) and Precision Medicine Quality. The Senior Manager, In-Vitro Diagnostics/ Precision Medicine Quality supports the use of In-Vitro Diagnostics (IVD), including Companion Diagnostics (CdX), and Precision Medicine applications to clinical development. This role is responsible for supporting the implementation of an end to end, proactive and risk-based Quality Assurance strategy for IVD, and Precision Medicine, including third-party collaborations.

The In-Vitro Diagnostics/ Precision Medicine Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development. This strategy will ensure that all Amgen’s business procedures meet internal and external quality standards, and that they are managed for optimum efficiency and effectiveness. The In-Vitro Diagnostics/ Precision Medicine Quality strategy also ensures that the business develops and manages fit for purpose standards (SOPs and quality agreements). In addition, the strategy will ensure that Amgen’s QMS is continuously improved upon using quality by design, risk assessments, and outputs from the Quality Management System, including analytics showing quality trends and potential continuous improvement opportunities.

Responsibilities

• Develop collaborative partnerships with Research and Development (R&D) to help establish the state of quality and potential areas of quality risk exposure. Contributes to the use of innovative methods for improving the quality oversight for Amgen’s IVD and Precision Medicine programs.

• Collaborate with colleagues in a cross-matrixed environment and ensure that Amgen’s R&D efforts, including partnerships and third parties, are aligned to industry best practices and all regulations.

• Support the implementation of IVD quality management strategies to ensure compliance to an evolving and complex IVD regulatory landscape, particularly in the European Union.

• Leverages metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine for Quality Management System performance and improvement.

• Collaborate with clinical trial teams to ensure that all respective critical to quality components are incorporated into clinical trial design, execution, and support of regulatory filings.

• Maintain up-to-date knowledge of IVD regulations and applicable guidance; monitor development of regulations and communicate impact to the business.

• Provides risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).

• Ensures that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of quality management experience OR

Master’s degree and 6 years of quality management experience OR

Bachelor’s degree and 8 years of quality management experience OR

Associate’s degree and 10 years of quality management experience OR

High school diploma / GED and 12 years of quality management experience

Preferred Qualifications:

• At least 3 years of experience in the pharmaceutical/biotech or medical device industry working within quality a quality management system role, or other relevant experience in clinical research that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support.

• An understanding of medical device development and applicable Global Regulations.

• An understanding of Precision Medicine and applicable Global Regulations.

• An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise (Sparta Systems).

• Experience preferred working within research and development of In-vitro Diagnostics.

• Implementation of technology to improve knowledge management across a diverse R&D environment.

• Experience with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.

• Ability to incorporate business and customer feedback into clear, efficient processes using a straightforward language and format.

• Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.

• Innovative thinking, including the application of quality by design principles

• Collaborative worker with an ability to support a high performing team.

• Excellent verbal and written communication skills, including strong business writing abilities and active listening.

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.

DIRECTOR, CLINICAL QUALITY THERAPEUTIC AREA LEAD

Live

What you will do

Job Description

Let’s do this! Let’s change the world! In this vital role you will report to the Associate Vice President, Clinical & Research Quality (CRQ) and be responsible for a team of 5-10 colleagues. The Director, Clinical Quality Therapeutic Area Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development program.

Director, Clinical Quality Therapeutic Area Lead will manage end to end Quality Oversight within one of three Therapeutic Areas (TAs): Oncology/Biosimilars, Immunology & Rare Diseases, and General Medicine. The TA Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will be a vital role who develops deep knowledge of the TA’s clinical trials and provides oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
• Provide oversight for the development and implementation of Quality Plans
• Establish Regional expertise to ensure quality and compliance to local regulations
• Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits)
• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Basic Qualifications:

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience

Or

Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience

Or

Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 5 years of managerial experience directly leading people in a multi-tiered organization and an ability to build a high performing team.
• 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. (including oversight of CAPAs, deviations, etc.)
• Thorough understanding and deep knowledge of Clinical Development activities / Clinical Trials and Global Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures.
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including strong business writing abilities and active listening.
• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities.

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.

Undergrad Intern - Global Supply Quality - Contract Manufacturing Quality

Live

This could be your everyday

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

Operations is one of three foundational functions at Amgen with a mission to manufacture and deliver safe and effective medicine to patients around the world. Utilizing external contracted manufacturing services is a key strategy to ensure the delivery of Amgen products to our patients. Global Supply Quality’s (GSQ) objective is to ensure the quality of the materials and products we receive from our external suppliers and contract manufacturers. The North America arm of Global Supply Quality is seeking a highly motivated, hardworking undergraduate to fulfill a 2024 summer internship role under supervision of the Director of the organization. This internship will be approximately 12 weeks and includes both project-based and experiential learning. This position is to be fulfilled in a remote work setting, with the possibility of travel to internship events at one of our locations. The intern will be an integral member of the North America Global Supply Quality organization and will be focused on applying innovation and data driven strategies to simplify processes. The areas to be supported include: Portfolio Management, Business Operations, and Continuous Improvement. As a member of Amgen's GSQ Organization, your work will be highly collaborative across multiple functions and levels within Amgen, including, for example: Quality, External Supply, Supply Chain, Engineering, Diversity, Inclusion & Belonging, and others. You will be uniquely responsible for one or more key projects that will advance GSQ’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 GSQ. 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 individual we seek should be self-motivated and display the following 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

• Majoring in Engineering or a Biotech related STEM discipline
• Interest in Project Management and Finance
• Strong communication, interpersonal, organizational, project management, and problem-solving skills
•  Strong analytical and quantitative skills
• Demonstrated personal initiative, self-motivation, flexibility and adaptability

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 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-179444

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