Vertex Pharmaceuticals Incorporated

External Manufacturing Associate Director (Boston) Job at Vertex Pharmaceuticals

Vertex Pharmaceuticals Incorporated, Boston, MA, US

Job Description

Associate Director, Cell & Gene Therapies External Manufacturing Operations - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (based in US, New England)

The primary focus of the Associate Director, External Manufacturing role is to oversee Vertexs critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this businesscritical function. We are looking for a candidate with breadth of professional experience and drive to work with internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through postapproval lifecycle management. The right candidate should have the ability to understand challenges and make proactive decisions after anticipating crossfunctional 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 CMO site and/or be able to travel up to 50% of their time to those sites as a PersoninPlant to oversee activities on the ground or as an SME to provide technical support. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to broader External Manufacturing group activities.

Key Responsibilities

Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs).
Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements (including but not limited to successful execution of manufacturing operations, ontime shipments, quality compliance and cost management); be Vertexs eyes and ears at the CMO for rightfirsttime execution of commercial operations.
Proactively connect the dots on emerging trends and issues and lead/influence crossfunctional teams to drive resolutions and minimize impact to compliance and delivery of safe and reliable supply.
Maintain onsite presence at CMO facilities for extended periods (including off hours/weekends) to oversee (i) critical program activities, (ii) clinical and commercial batch manufacturing until the CMO is sustainably executing operations, and (iii) Health Authority inspections.
Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure crossfunctional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply.
Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities including but not limited to (i) contract management (including tracking KPIs and metrics e.g. for batch release, inventory targets and schedule attainment), (ii) forecast communication and schedule alignment, (iii) supplier governance (including Vertex Quality/other audits) and (iii) finance (e.g., issuance of POs and reconciliation/validation of invoices; tracking of spend vs budget).
Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
Manage and track batch data in compliant (dataintegrity) systems to support filing submissions, patient planning and process optimization.
Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements.
Identify and elevate businesscritical issues to Commercial Manufacturing and Supply Chain, CMC, and Quality leadership.
Collaborate with CMO and internal stakeholders to understand planned changes and manage the endtoend implementation of agreed changes including but not limited to change controls and impact assessments.
Lead continuous improvement initiatives to affect timely resolution of supply issues.
Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders.

Minimum Requirements

Bachelors degree required, ideally in cell biology or a closely related Life Sciences discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role 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 express oneself clearly and concisely, 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 fastmoving environment of uncertainty and change.
Flexibility to work shift hours required to cover critical process steps.
Ability to travel, national and international, up to 50%.
Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces, and electronic quality systems.

Desired Additional Skills

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 CMOs.
Cleanroom qualification (GradeA/B) history.

Environment

Office and cleanroom must be able to comply with cleanroom gowning requirements at CMO.
Must be able to remain in a stationary position 50% during cleanroom processing activities.
Must be comfortable moving around inside the cleanroom to oversee process tasks.
Compressed gasses and LN are commonly used in manufacturing operations.
Human tissue (e.g., apheresis) and cellular materials are commonly used.

Pay Range: $160,000 - $240,000

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 jobrelated factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive marketleading 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 weeklong 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.

Flex Designation

RemoteEligible

Flex Eligibility Status

Remote : work remotely five days per week and come into the office on occasion you're always welcome onsite.
Hybrid : work remotely up to two days per week.
OnSite : work five days per week onsite with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.