Vertex Pharmaceuticals

The primary focus of the Associate Director/Principal Engineer, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) and implement our vision for this business-critical function.. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management.. The candidate will be located either at the cell and gene therapy CDMO's site and/or be able to travel to those sites routinely as a "Person-in-Plant".. Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs). Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience.

manufacturing associate

Job Description
The primary focus of the Associate Director/Principal Engineer, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located either at the cell and gene therapy CDMO's site and/or be able to travel to those sites routinely as a "Person-in-Plant". The successful candidate will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.
Candidates should be located in /near Boston, MA or Portsmouth, NH.
Key Duties and Responsibilities:
* Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs)
* Provide operational oversight of, and troubleshooting support to, CDMOs 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) - be Vertex's eyes and ears' at the CDMO for flawless execution of commercial operations
* Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities. It is anticipated that routine Person-in-Plant oversight will decrease over time.
* Liaison with internal and CDMO stakeholders and leadership on business operations including but not limited to contract management, forecast communication, compliance and finance (eg. issuance of POs and reconciliation/validation of invoices).
* Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. This includes working closely with CDMO and internal stakeholders on preparations for pre-approval inspection and commercialization-readiness.
* Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
* Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization.
* Work closely with CDMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations, and deviations) to meet Vertex program requirements.
* Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs.
* Establish a robust tracking and reporting process to ensure compliance with KPI's, internal/external audit observation deadlines or other regulatory commitments.
* Collaborate with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments.
* Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity
* Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership.
* Lead continuous improvement initiatives to affect timely resolution of supply issues.
* Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
* Live the Vertex values.
Education and Experience:
* BS /BA in in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 8+ years of relevant experience in biotech or pharmaceutical industries, working with or in cGMP facilities within the biotechnology industry.
* Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
* Strong technical background in aseptic manufacturing operations.
* Solid project management skills and experience managing complex projects.
* 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.
* Strong leadership and an innate ability to collaborate and build relationships is critical.
* Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
* Flexibility to work shift hours required to cover critical process steps
* Ability to travel, national and international, up to 30%
* Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience.
* Solid experience in equipment and facility qualification and validation for ATMP CDMO's
* Represent Vertex as a leader when issues arise.
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Salary range: $152,000 - $228,000 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
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.<br/><br/>#J-18808-Ljbffr

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