Total 26 job vacancies by Vertex Pharmaceuticals Inc (US)

Job Description

Executive Director/Senior Director, Global Commercial Strategy Pain

Boston, MA (3 days onsite, 2 days remote weekly)

Vertex Pharmaceuticals is seeking a Executive Director or Senior Director of Global Commercial Strategy reporting to the VP Global Commercial Lead for Pain to join our dynamic team in Boston, MA. The candidate will take responsibility for global marketing decisions and tactics that lead Life Cycle Management, portfolio and commercial strategy development whilst supporting the team on successful launches on the pain programs. This will involve shaping global commercial strategy in pain portfolio and developing both strategies and resources to be used by the Regions in their interactions with stakeholders for years to come.  The successful candidate serves as a voice of the community to ensure patients remain at the center of decisions.

The candidate will play a key role in leading the development of the Pain Portfolio strategy.  The role will have a strong focus on Vertex’s outlook in pain across assets, indications and geographies.   This role will integrate launch preparation for ‘Next in class’ molecules with New Product planning.  They will lead development of key deliverables of Pain portfolio strategy including the 3–5 year commercialization strategy. A member of the Early Pipeline team (PT), the coordinating body for the portfolio pipeline in pain, will work closely with cross-functional matrix colleagues to ensure attainment of corporate objectives. The candidate will be the ‘right hand’ to the commercial lead for Pain ensuring aligned commercialization position on pipeline for the Disease Strategy Team and senior leadership. The successful candidate is highly strategic, thrives in an environment of uncertainty and rapid change, demonstrates strong leadership, works effectively within cross-functional teams, and has a problem-solving mindset backed by strong analytical skills. The candidate must share our passion for science-based brands that can dramatically improve patients' lives.

As a senior member on the pain team, the successful candidate must be able to role model Vertex’s ethics & culture and be committed to developing the next generation of leaders.

Key Responsibilities:

• Lead and ensure successful development and implementation of the commercialization (midterm) and portfolio (long term) strategies including brand development, competitive strategy, go-to-market/launch, and lifecycle decisions for future launches. Execute in close partnership with the Regions, Market Access, Regulatory and Commercial Manufacturing.

• Deliver foundational insights about the evolving landscape of pain today and in future, with focus on patients and providers, managing external consultants together with Marketing Science and Market Access

• Execute key global initiatives to prepare the market, enable strong uptake and sustain commercial success.

• Play a key role on the Early PT, integrating commercial position into pain pipeline strategy. There will also be potential to lead ‘Next-in-Class’ PT.

• Support the Global Commercial Team by providing clear direction for the pain portfolio as the primary forum for commercial collaboration and alignment.

• Represent the Commercial team in projects led by others e.g. label development, initiatives, etc.

• Partner with RWE and HEOR to continually evolve our understanding of addressable patient populations, providing input to relevant cross-functional teams (ClinDev, GPMA, HEOR).

• As a senior member of Global Commercial Strategy Pain team they will provide a mentoring/role model to the team.

Qualifications

• Bachelor’s degree required, ideally in life sciences

• Typically requires 12+ years of work experience or the equivalent combination of education and experience  

• In country launch experience, particularly in small molecule/pain, US market experience required and multiple-market experience highly desired.

• Experience in global marketing, new product planning as well as commercial operations or analytics desirable, especially involving product launches.

• Demonstrated ability to work independently and manage initiatives that require collaboration across multiple functional areas.

• An entrepreneurial spirit and an ability to develop creative solutions to complex problems.

• Excellent communication skills

• A solid compliance mindset, demonstrated integrity on the job, embrace of the Vertex Values. 

• Vertex welcomes applicants from diverse backgrounds and promotes an inclusive work-place environment.

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Company Information

Job Description

General position summary:

The Associate Director, Quality role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the US in compliance with GDP and GMP requirements.  The position will manage the day to day Quality oversight of the Third Party Logistics provider and provide support for key stakeholders within Vertex. 

This Position Reports to: Director, GDP Operational Quality, International QA

Key Accountabilities:

• Serve as the primary contact and have oversight of Distribution and Logistics partners within the US, including:
  • Preparation and maintenance of Quality Agreements
  • Review of deviations, CAPA and changes
  • Maintaining KPIs
  • Analyze, resolve, or assist in solving compliance and customer issues.
  • Escalation of issues
• Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
• Working collaboratively with key internal stakeholders

Key Responsibilities:

• Maintain QMS within the Vertex Inc.
• Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessary
• Support recalls, mock recalls and any other on-market activity.
• Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
• Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.
• Planning/ Preparation/supporting/hosting for Regulatory inspections
• Providing front and backroom inspection support
• Post inspection follow-up with responses and CAPAs (Continuous improvements)
• Manage/Approve/Assess event investigations “deviations” (including Fast Track deviations)
• Manage CAPAs and Effectiveness Checks
• Perform other duties as per GDP guidelines and Vertex policies and procedures
  • Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.
  • Ensure that customers and suppliers are approved
  • Approving any subcontracting activities that may impact GDP.
  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
  • Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.
  • Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Create/review and approve Standard operating Procedures and other Quality Documents

Minimum qualifications:

Master’s degree and 4-5 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.

Preferred Qualifications:

• Bachelor's in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background.
• 5+ years’ experience serving in a Quality role.
• Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
• Influencing skills in areas with no direct reporting authority.
• Strong interpersonal and communication skills.
• Auditing skills, appropriate qualifications in auditing an advantage.
• Fluency in English is required
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select

On-Site: work five days per week on-site with ad hoc flexibility.

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Company Information

Job Description

General Summary:

The Quality Systems Director provides technical and strategic leadership for quality systems, quality governance, and quality culture for the cell and gene therapy business unit.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
• Leads and drives improvements to quality governance forums identifying risks and driving overall compliance and quality maturity
• Provides oversight, support, and drives continuous improvement to quality systems such as change control.  Focuses not just on the process, but the content and compliance of the executed records and helps drive maturity throughout the overall organization.   
• Participates in cross-functional projects in Quality expert and leader role
• Collaborate with internally and external business partners across the organization
• Provides strategies and tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• As a people manager within the organization, provides leadership, development and coaching to staff, in addition may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Strong technical knowledge including but not limited to: QMS, risk management, change control and governance.
• Solid quality culture knowledge and understanding of how to influence and improve overall compliance
• Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
• Experience across multiple GxP areas
• Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

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Company Information

Job Description

Vertex Pharmaceuticals is seeking a Health Economics & Outcomes Research (HEOR) Associate Director - pain to join the North America HEOR team.  This role will support and develop key HEOR tactics to ensure successful commercialization of novel NaV 1.8 inhibitors for acute and chronic pain in the United States (US) and Canada. This person will work in a highly cross-functional matrix team environment to ensure a seamless alignment of HEOR projects within the broader market access, policy, and medical strategy.  This person is expected to exhibit a strong sense of urgency to achieve corporate objectives while maintaining the highest ethical, regulatory and scientific standards.  This position reports to the Director, Pain launch lead, North America HEOR.

Key Responsibilities

• Own development of tactics for innovative HEOR solutions and deliverables that directly support optimal patient access to in the US and Canada throughout the product’s lifecycle  
• Drive the development of external customer-facing value demonstration tools in accordance with regulatory standards, in close collaboration with formal review bodies (e.g., Commercial Review Committee; Medical Review Committee) while supporting appropriate field teams (e.g., field HEOR, payer team)
• Work closely with global HEOR team to provide the US and Canadian perspective to evidence generation activities and to ensure timely and effective translation of HEOR studies for field use
• Directly engage with external customers (e.g., payer accounts) to deliver HEOR presentations when appropriate/requested
• Own execution of local HEOR studies in partnership with customers (e.g., payers, integrated health systems)

Qualifications

• Advanced degree (e.g. PhD, MD, MPH, or PharmD) in a scientific discipline.  
• Typically requires 8+ years of experience, with substantial background in HEOR, or the equivalent combination of education and experience. US launch experience in pain and/or other primary market experience is preferred.
• Robust understanding of the 2018 FDA Payor Guidance to payer communication in the US is strongly preferred.
• Understanding of the HTA process and methodology; hands-on experience with HTA dossier submission and review is preferred.
• A track record of peer-reviewed publications demonstrating experience in COAs, observational research, and/or health economic modeling.
• Strong communication skills, both verbal and written, including the ability to effectively present to both internal and external audiences
• Results oriented and excellent analytic and project management skills. 
• A strong sense of urgency and commitment to patients

This is a hybrid eligible role requiring at least 3 days on-site in Boston office.

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Company Information

Job Description

The Senior Medical Director, Patient Safety, Disease Area Safety Head (DASH) will lead all safety and benefit-risk related activities for products within the role's Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization. This role will assist Global Patient Safety (GPS) Leadership in ensuring the consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Directly and/or via oversight of direct reports, the role will lead pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with the program specific Clinical Teams, Medical Affairs, and Partners (as applicable) to proactively assess and address potential and identified safety issues for each product throughout the product life cycle.

Key Duties and Responsibilities:

• Provides leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre-FIH activities, benefit-risk assessment, and strategy for DSTs.

• Coordinates and oversees safety signals detection, in accordance with Vertex signal detection practices.

• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, as needed.

• Collaborates with NDA teams in support of submissions, specifically leading development of any SCS, CLO, Label and Risk Management Plan (RMP) or equivalent documents.

• Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies.

• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (D/PSURs), IND packages, as well as NDA and IND, MAA Annual Safety Reports.

• Provides review and safety-specific input for labeling documents.

• Collaborates with Regulatory Affairs to develop responses to safety related regulatory agency inquiries.

• Provides and oversees medical review of aggregate and individual post-marketing and clinical trial AE reports, in accordance with GPS review practices.

• Conducts medical evaluation of relevant safety information from Toxicology, Non-Clinical studies and Product Quality sources.

• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Analysis Plan, IB, ICF and IDMC Charter.

• Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and Study Reports.

• Provides contributory to Partner /Affiliate agreements and interactions, as needed.

• Serves as Subject Matter Expert in departmental activities, SOP development.

• Facilitates the growth and development of staff and direct reports.

Knowledge and Skills:

• Broad and comprehensive knowledge of General Medicine

• Extensive knowledge of GCP, ICH and Global regulations

• Strong leadership skills with the ability to communicate effectively in a matrix environment

• Experience in the critical evaluation and interpretation of data, with ability to synthesize into coherent messaging

• Comprehensive knowledge of Benefit-Risk strategies and decision-making

• Ability to multi-task, adeptly handling multiple demands

Education and Experience:

• Doctorate in Medicine (M.D.) required

• 7+ years of work experience with some experience in Pharmacovigilance and 5 years of supervisory/management experience, or the equivalent combination of education and experience

Company Information

Job Description

Vertex is seeking a detail-oriented Package Engineering Senior Specialist with technical expertise in pharmaceutical packaging, process development and continuous improvement initiatives. The ideal candidate will provide technical support in packaging operations, working with cross functional teams in a fast-paced environment.  Candidate will need to ensure resolution of technical issues with Contract Manufacturers and Distribution Centers.  They will support projects with on-time review and implementation of documentation, and change controls. Candidate should have excellent problem solving, organizational, interpersonal, oral, and written communication skills, and experience with technical writing, cGMP and regulatory CMC requirements.

KEY RESPONSIBILITIES:

• Provides technical support on Packaging processes to Package Engineering and cross functional teams
• Author and/or review validation and change control documents such as master batch records, protocols, reports and change requests.
• Experience in software systems for validation protocols, change controls, CAPAs and Deviations.
• Experience with common primary, secondary, and tertiary packaging materials
• Supports packaging projects and process improvement efforts (IE New Product Introductions, validations, equipment installation, IQ/OQ/PQ protocol development and execution
• Ability and flexibility to work globally in a virtual work environment
• Excellent project management experience
• Ability to multitask to effectively manage multiple activities and projects
• Ability to collaborate with and communicate results to relevant stakeholders
• Strong analytical, problem solving and communication skills
• Develops solid working relationships with relevant technical individuals or teams at contract manufacturing sites
• Will require travel periodically to contract manufacturing plants to support process performance or to troubleshoot manufacturing issues 
• Complies with all Quality, Regulatory, Health, Safety, and Environmental responsibilities for the position
• Supports the responsibilities of the Packaging LCM team in projects related to packaging technology, sustainability, and industry activity
• Experience or certification in LEAN and/or Six Sigma practices is a plus

Education and Experience:

• Typically requires Degree in Packaging, Biomedical, Mechanical, Chemical, or Industrial Engineering or a related field.
• Minimally requires 3 years of experience or the equivalent combination of advanced education and experience.

Required Knowledge/Skills

• Advanced knowledge of cGMP’s and associated CMC regulatory considerations in a pharmaceutical environment
• Fundamental understanding and application of validation processes (IQ/OQ/PQ/PV)
• Solid communication, collaboration and team building skills; ability to connect with all levels of the organization
• Demonstrated ability to manage multiple projects concurrently, and flexibility to accommodate changes in responsibilities or project priorities

Other Requirements

• Ability to travel domestic and international. (Approximately 25%)

Company Information

Job Description

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams, including pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables.

Key Duties and Responsibilities:

• Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives.

• Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices.

• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed.

• Collaborates with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents.

• Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed.

• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs.

• Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable.

• Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.

• Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices.

• Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources.

• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter.

• Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.

• Reviews and provides oversight of safety sections of clinical study reports.

• Provides a contributory role in Partner /Affiliate agreements and interactions, as needed.

• Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.

• Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.

• Leads and guides direct reports, regarding the scope of DASH/DST Chair Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities.

• Facilitates the growth and development of staff and direct reports.

Knowledge and Skills:

• Extensive knowledge of GCP, ICH and Global regulations.

• In-depth and comprehensive knowledge of General Medicine.

• Strong leadership skills with the ability to communicate effectively in a matrix environment.

• Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging.

• Extensive knowledge of Benefit-Risk strategies and decision-making.

• Ability to multi-task, adeptly handling multiple demands.

Education and Experience:

• MD, DO or equivalent ex-US medical degree

• 12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience

Company Information

Job Description

Company Information

Job Description

The External Manufacturing Senior Manager will drive manufacturing operations and execution at Vertex’s external commercial partner(s) for the manufacture of Small Molecule Drug Product, while contributing to the broader External Manufacturing group activities. The candidate will be in a remote role, with travel to US and EU CDMO sites routinely as a “Person-in-Plant” 2-4 weeks per month.

Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain (CMSC) team’s role in ensuring that Vertex effectively and efficiently delivers medicines to patients. As such, we are looking for a leader to provide leadership, and both strategic and enterprise thinking in the management of the external partner.  The candidate should have broad professional experience and the drive to work with both internal and external stakeholders to define and manage the execution of ongoing cGMP manufacturing of Drug Product supplies. This leader should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities.  They should have the ability to cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.

Key Responsibilities:

• Acts as main point of contact for CDMO(s), building and maintaining strategic relationships within the CDMO organization.  
• Responsible for driving execution of Drug Product production plans: Provide operational oversight and troubleshooting support to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management).   
• Maintain on-site presence acting as the Person-in-Plant (PiP) at the CDMO facility and be Vertex’s eyes and ears to ensure flawless execution of commercial operations. This may include some off-hours/days to resolve urgent issues.
• Lead continuous improvement initiatives to affect timely resolution of supply issue and increase productivity.
• Partners with Tech Ops, Quality and CMSC Strategy and Business Operations to champion a culture of quality with our CDMO’s and to ensure that all activities and documentation comply with regulatory requirements.
• Establish a robust tracking and reporting process to monitor CDMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
• Leads identification and resolution of business-critical and contract issues; leading escalations to CMSC and Quality leadership.
• Champions a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement.

Minimal Requirements:

• BS/BA degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline
• Requires 8 years or more of relevant experience in biotech/pharmaceutical industry. 
• Understanding of the science and technology underlying Small Molecule Drug Product manufacturing as well as analytical techniques that support commercial manufacturing activities.
• Demonstrated understanding of the technical aspects of manufacturing, testing, and controls; engineering; plant operations; the regulations governing pharmaceutical operations, as well as financial systems and controls.
• Strong quality and compliance background in a commercial GMP operational environment
• A strategic thinker with strong result-orientation, and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor.
• Excellent team player and be able to build and sustain organization respect and trust at all levels both internally and externally.
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them.
• Resilient and able to work well in a demanding, fast paced entrepreneurial environment.
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Flexibility to work shift hours required to cover critical process steps and troubleshooting.
• Ability to travel, national and international, up to 100%
• Experience in aseptic manufacturing operations

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Salary range: $132,800 - $199,200 annually

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. 

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. 

Company Information

Job Description

General Summary:

Vertex is seeking a talented individual to join our Analytical Development – Process Analytics and Control group in Boston, MA.  As a member of the Process Analytics and Control team, this individual will also be a member of the industry leading continuous drug product manufacturing team supporting drug development programs at Vertex.  The Process Analytics and Control team is responsible for the automated control strategy for drug product continuous manufacturing and the development/validation of PAT methods.  Specifically, the role will focus on development and maintenance of process analytical technology, the implementation of the automated control strategy, and the validation of Process Analytical Techniques (PAT) methods, automation, and data reporting.  

Key Duties and Responsibilities:

• Supporting GMP continuous manufacture, including leading PAC activities in support of clinical and commercial manufacturing
• Managing and coordinating activities related to qualification and maintenance of PAT equipment
• Leading the development and validation of automation control software related to continuous manufacturing.
• Developing a control strategy and implementing PAT methods (NIR, Raman, particle size) and data models to support manufacturing unit operations.
• Presenting to and aligning with cross functional teams on critical issues and solutions
• Authoring and reviewing documents required for a cGMP environment.
• Authoring, reviewing, and assessing quality events including change controls, deviations, and CAPAs
• Supporting inspections by regulatory agencies

Knowledge and Skills:

• Experience managing a team, coordinating resources and delivering results is essential
• The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects
• The ability to work successfully in both a team/matrix environment as well as independently i
• Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals
• Hands-on experience developing, integrating, and maintaining analytical or process instrumentation  

Education and Experience:

• PhD (physical sciences, mathematics or engineering) and 2+ years, or Master's and 5+ years, or Bachelor's and 8+ years or equivalent experience.

Company Information

Job Description

Vertex has established a research site in Boston Seaport where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies, and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. 

Vertex is seeking a talented individual to join our Process Development group. The primary focus of this talented individual is to lead part of the process development/engineering scale-up activities for drug substance processes for one of our key cell and gene therapy assets. The position is responsible for internal process development work, translating small scale experiments, which generate fundamental process understanding, into bioreactor systems which can be scaled up according to program requirements. The position will be based in our Boston, MA facilities.

The successful candidate will be a subject matter expert in protein biochemistry, process engineering, or similar relevant field(s), and have a solid technical operations background. 

 
Key Responsibilities

• Lead the design and execution of experimentation to develop robust and scalable manufacturing processes for cell therapy products and implementation to support programs in clinical development. 
• Evaluate and implement novel technologies and equipment platforms for next-generation cell therapy manufacturing processes and establish scale-up parameters.
• Collaborate effectively with internal and external partners and leads projects with a fully integrated team to facilitate successful outcomes.
• Coordinate resources and sets priorities for own team, contributing to the overall goals of the department
• Generate and review technical reports, regulatory filings, source documents, patents and external publications.

Minimum Requirements

• A BS in Biochemistry, Engineering, Biology or related discipline with 8+ years of industry experience or a MS with 6+ years of industry experience or a PhD with 2-5 years of industry experience
• Strong fundamental knowledge in cell culture process development, bioreactors across scales, and scale-up design, as well as knowledge of recent advances, and challenges in the field
• Experience in design of experiments (DOE) and statistical analysis
• Willingness and ability to effectively lead a team
• Strong verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to rapidly changing priorities
• Excellent organizational skills and high attention to details 

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Company Information

Job Description

General Summary:

The Sr. Principal Oracle EBS Project Costing Lead will be a key technical resource in ensuring the planning and delivery of key commercial-off-the-shelf (COTS) and a wide range of custom solutions in support of their business partners in Accounting and Finance. The Business Engagement & Technology Senior Principal Analyst for Accounting will partner with business leadership in Accounting and Finance to develop capabilities and systems roadmaps that align to support business strategy. Additionally, the Business Engagement & Technology Senior Principal Analyst for Accounting will ensure team members maintain reliable, scalable and compliant systems that easily meet business needs by efficient delivery and enhancements that provides opportunities for developing and implementing innovative solutions and integrations.

Key Duties and Responsibilities:

• Become a trusted partner of the business leaders within their remit
• Understand their needs and vision, and deliver technology solutions to support and enable their goals and objectives
• Engage as a key participant in the strategic business planning process for their business partners
• Provide insights on how technology can improve business processes to enable operating efficiencies and support the achievement of business goals and objectives.
• Articulate and maintain a technology strategy to support and advance the business' objective. This strategy should factor in an understanding of future directions of the business area, as well as changes in the technology landscape.
• Execute the technology strategy by leading the evaluation, selection, implementation, and ongoing maintenance of technology solutions.
• Establish, track and report on project value drivers and financial impact
• Work closely with DTE Compliance, Internal Audit, and Quality Assurance groups as needed to ensure compliance with all appropriate regulations, as well as our DTE system lifecycle and change management requirements

Knowledge and Skills:

• Expertise in Oracle eBusiness Suite Project Accounting module with in-depth experience in Project Costing including budgeting, accrual, and expenditure capture – both internal costs from other Oracle modules as well as from integration, rule based general ledger account generation, capital asset creation and CIP cost collection functionality.

• Experience in other Oracle eBusiness Suite Financials Applications portfolio including General Ledger, Fixed Assets, Cash Management, Payables and Receivables modules.
• Experience in Financial close processes within Oracle eBusiness Suite.
• In-depth and specialized knowledge in the core disciplines of project management, business analysis, solution design, delivery and training
• Significant experience in building productive partnerships with business stakeholders and influencing them to take action
• In-depth and specialized understanding of the business, processes, and any appropriate regulatory environments
• Results oriented manager with a proven track record of on-time project delivery for large, complex projects with global stakeholders
• Exceptional written and verbal communication skills and ability to present in a clear and concise manner to all audiences
• Exceptional analytical, quantitative, problem-solving, and prioritization skills, including the development of business cases/ value propositions
• Substantial program/ project management, demand management, resource management and system life cycle expertise
• Strong analytical and problem-solving abilities including development of business case / value propositions
• Superior MS Office skills, including MS Project & Visio, Excel and PowerPoint Experience
• Strong experience in Agile methodology

Education and Experience:

• Bachelor's degree in technology discipline or equivalent
• Typically requires 9 years relevant business systems in the Life Sciences industry, or the equivalent combination of education and experience

Company Information

Job Description

External Manufacturing Sr. Manager, Person in Plant (Finished Goods)

The primary focus of the Sr. Manager role is to oversee operations of Vertex’s external US commercial partner(s) for the manufacture of small molecule finished goods products. The incumbent will lead the internal virtual plant team that oversees the operations at the CDMO and co-lead joint project teams with the CDMO, while contributing to the broader External Manufacturing group activities. The candidate will be located close to the US CDMO site(s) outside of Philadelphia, PA and/or be able to travel to those sites 3 days/week as a “Person-in-Plant”.

Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain team’s role in ensuring that the company effectively and efficiently delivers medicines to patients.  As such, we are looking for a leader to provide vision, leadership, and both strategic and enterprise thinking in the management of the external partner.  The candidate should have broad professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of finished goods. The Sr. Manager will provide vision, leadership, and strategic thinking in the management of the external partners. This leader will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.

The Sr. Manager will report directly to the Director, External Manufacturing Operations. This leader should have a strong operational, quality, compliance, and technical background, with proven project management and supplier management abilities.  They should have the ability to cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.  

The candidate will be in a remote role, with travel to CMO sites routinely as a “Person-in-Plant”. This role will be accountable for all Finished Goods external commercial manufacturing operations activities in the US for small molecules. This role will partner closely with colleagues across Vertex to ensure a seamless supply of all Finished Goods commercial products. 

Key Responsibilities:

• Acts as the main point of contact for CDMO(s) including the leader of the CDMO VPT/working team. 
• Responsible for driving execution of commercial and late stage/launch production plans: provide operational oversight, and troubleshooting support, to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance, and cost management).  
• Maintain on-site presence acting as the Person-in-Plant at the CDMO facility and be Vertex’s first point of contact to ensure flawless execution of commercial operations. This may include some off-hours/days to resolve urgent issues.
• Lead continuous improvement initiatives to affect the timely resolution of supply issues.
• Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
• Partners with Tech Ops, Quality, and CMSC Strategy and Business Operations champion a culture of quality with our CDMOs and ensure that all activities and documentation comply with regulatory requirements.
• Monitor CMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
• Supports identification and resolution of business/contract issues (bring in legal, CMSC LT, Strategy+Bus Ops, Strategic Sourcing).
• Partners with Global Supply Chain to develop a long-term manufacturing network strategy and to maintain a flexible, reliable, robust, and cost-effective manufacturing network.
• Champions a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement.

Minimal Requirements:

• 8+ years of progressive experience in a leadership/management role in pharmaceutical development and commercial manufacturing
• Understanding of the science and technology underlying Finished Goods manufacturing as well as analytical techniques that support commercial manufacturing activities
• Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, maintenance, and engineering
• Strong knowledge of cGMP requirements
• A strategic thinker with a strong result orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• Understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls
• Excellent communication and interpersonal skills with the ability to work in strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor
• Excellent team player and able to build and sustain organizational respect and trust at all levels
• Problem solver with a hands-on approach and the ability to anticipate adverse scenarios and provide contingency plans to address them
• Resilient and able to work well in a demanding, fast-paced entrepreneurial environment
• Sound judgment and business acumen with personal versatility and flexibility as business and team evolve
• Keeps current on professional knowledge, expertise, and best practice.

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Salary range: $132,800 - $199,200 annually

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. 

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. 

Company Information

Job Description

Executive Director, Logistics, Supply Chain Management - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (Boston)

This critical senior position will be responsible for building and leading the Global Logistics Organization within the Commercial Manufacturing and Supply Chain (CMSC) Division. Vertex is rapidly commercializing a pipeline of exciting programs and growing our capabilities to support the supply chain and manufacturing of these therapies. The head of this group will be responsible for defining and delivering the global logistics strategy for commercial therapies and a set of complex pipeline programs.  This strategy includes logistics network design, validation planning and life cycle management for all modalities (small molecule and cell and gene therapies).   The Executive Director will establish logistics as a key strategic pillar to enable successful clinical development and commercialization.

The Executive Director has interaction and impact across multiple Vertex departments and will represent the logistics organization in several executive forums. The Executive Director is responsible for delivering successful product launches across all programs. The Executive Director will cultivate and leverage multiple cross-functional business relationships to deliver a robust logistics strategy.    

This role will report to the VP of Supply Chain Management within the Commercial Manufacturing and Supply Chain (CMSC) division. This supply chain leadership position will be responsible for identifying future capabilities required and building out a high performing, diverse team focusing on developing and implementing a robust logistics strategy and well-controlled operations. The position is based at Vertex’s corporate headquarters in Boston, MA.

Key Responsibilities:

• Define a comprehensive global logistics strategy for a set of diverse pipeline and commercial programs in alignment with Vertex’s corporate strategy.  This strategy includes defining a robust logistics network of global providers to enable successful commercialization.  It also includes a 3-5+ year forward looking assessment of commercial forecast scenarios and associated materials movements to define logistics network expansion and systems requirements.  The role will establish long range optimization strategies to scale and deliver an integrated, best-in-class logistics.    
• Deliver reliable logistics operations, managing thousands of global shipments annually. This operation includes complex and diverse shipments from raw materials through finished goods for small molecules and short lead time, cold chain shipments for cell and gene therapy programs. The operation must deliver reliably for customers with problems being anticipated and mitigated before causing disruption.
• Responsible for defining and tracking global logistics budget.   The Executive Director will partner with Finance to establish the annual logistics budget based on prior year performance and forward-looking forecast.  Once established, the role is accountable for performance within budget and will identify opportunities for cost savings across the logistics network.
• Responsible for proactively assessing risk across logistics operation and developing business continuity plans.   The risk assessment includes couriers, warehouses and lanes for raw materials though finished goods. Risk mitigation and business continuity plans will be delivered to ensure timely, compliant delivery of materials across the supply chain.
• Deliver an integrated inspection readiness and logistics launch plan for Vertex’s Cell and Gene therapy and small molecule programs. The inspection readiness and launch plans include cold chain validation, lane identification, couriers, service level agreements and customer support models. The role will interact with multiple contract manufacturers, warehouses and couriers to train, onboard and successfully launch. The role will also include integration of systems requirements and complicated short-lead time cold chain logistics.  The Executive Director is responsible for leading the team through inspection and launch readiness, including making risk-based decisions to enable program success.
• Drive excellence in end-to-end operations through identification and management of key supply chain KPI’s.  Establish service level agreements and KPI’s throughout network.  Monitor KPI’s, deviation rates and performance across a complex network of providers. Drive operational efficiency, flawless execution and continuous improvement across the supply chain to deliver a best-in-class logistics organization. 
• Build a high performing team including forward looking organizational design requirements to scale to meet Vertex’s future vision.   Foster team culture, build trust and establish clear roles and responsibilities.
• Maintain an external network to stay updated on industry trends, emerging technologies and best practices in logistics.
• Champion the culture of quality and ensure that all activities and documentation comply with global regulatory requirements. Understand and implement processes and controls that align with GDP, evolving Health Authority, import/export and other regulatory expectations.  

Minimal Requirements:

• 12-15+ years progressive experience in supply chain, logistics and/or manufacturing leadership roles in the pharmaceutical industry. Experience with Biological products and Genetic and Cell Therapy technologies is strongly preferred.
• Experience in building and managing a complex global supply chain logistics operation.
• The candidate is expected to be a thought leader in logistics and supply chain and have a proven ability to innovate and implement practical, compliant solutions.
• A proven ability to work seamlessly across teams and develop excellent partnerships with peers.
• Demonstrated understanding of the principles and regulations associated with GDP operations.
• A results-oriented leader with a sense of urgency to deliver quality results in a highly ethical and professional manner.
• Motivational leadership of a cohesive high-performing team within a global, matrixed environment; the ability to articulate vision and successfully drive execution.
• Excellent communication and interpersonal skills with the ability to communicate complex issues and solutions enterprise-wide.
• Excellent team player who is able to build and sustain respect and trust at all levels of the organization.
• Ability to anticipate adverse scenarios and provide contingency plans to address them.
• Sound judgment and business acumen with personal versatility and flexibility as the business and team evolves.

Company Information

Job Description

Company Information