External Manufacturing Program Lead
3 months ago
Job Description
The primary focus of the exa-cel Program Lead role is to support External Manufacturing (ExM) with managing various activities to support execution of CMC, Clinical and Commercial manufacturing but also drive and support execution of strategies for life cycle management. This role will also provide leadership for project management activities and business processes such as SOW/PO and management of elements of batch disposition.
Key Responsibilities
- Manage on-time disposition of batches. This activity includes managing successful closure key components of exa-cel drug product disposition such as batch records and deviations, environmental monitoring, internal and external analytical testing. Close liaison with internal and CMO staff will be required to monitor daily, communicate progress and/or escalate to Virtual Plant Team (VPT) and Supply Chain and drive resolution for key issues.
- Provide project management support to the VPT for ‘run the business’ and life cycle management activities. These tasks may include collaboration with internal and external stakeholders through joint project teams, support/leadership for initiatives / projects, disposition, and other business priorities. This role will also support coordination, maintenance and facilitation of QMS data to support timely disposition of products. Provide support to VPT and the Global Manufacturing Operations Team (GMOT) with meeting logistics (including coordination of agendas, issuing meeting minutes, following up on open actions, recording of decisions), tool/system enhancement, collation of data and maintenance of dashboards for KPI performance. The role will also support initiation and closure of quality records such as deviations, CAPAs and/or Change Controls.
- Function as the primary point of contact for the ExM PO/SOW business process, establishing and maintaining business processes while collaborating with cross functional colleagues in Finance, Legal, and other technical teams to track against budget. This role will also collaborate with the Contract Manufacturing and Development Organizations (CDMO) and VPT on the intake of the Scope of Works (SOWs) and coordination of the internal review and approval of these documents. The responsibilities include initiating Purchase Orders (POs) and management of POs and invoices.
- ExM Business processes - take the lead identifying internal/external systems and gaps, then align, and share best practices. Ensure ExM US and International business systems stay aligned. Look externally to understand best practice and bring in house. Work closely with internal Project Management Office to stay aligned with best internal practices.
- Provide oversight to the training curriculum for ExM Cell and Gene Therapies and Small Molecule organization. This activity will include auditing of the training requirements for various levels to ensure accuracy and liaison with the training function to make proper adjustments. Partner with the ExM team to monitor training adherence. Closely partner with the Project Management Organization for sharing of experiences and tools.
Minimum Requirements:
- Bachelor’s degree in life sciences or related field. Industry knowledge and experience with manufacturing and quality environments.
- Strong quality mindset in a commercial GMP biopharmaceutical operations
- Solid project management skills and experience managing complex projects.
- Strong verbal and written communication skills: ability to express 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.
- Represent Vertex as a leader when issues arise.
Preferred Requirements:
- BS /BA in in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with broad relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing leadership role working with or in cGMP facilities within the biotechnology industry.
- Strong technical background in ATMPs, including cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience.
- Experience operating effectively in a matrix team environment.
LI-Hybrid #LI-MS1
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
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