Director, Process Development Engineering (MSAT), Cell and Gene Therapy

Vertex Inc. • Boston, MA

1d • Onsite

About The Position

General Summary: Vertex is seeking a talented individual to join our Process Development organization supporting our cell, gene and biologics pipeline. The primary focus of the Director is driving execution of Vertex’s cell, gene and biological therapy program objectives with internal and/or external manufacturing partners (CDMOs). The position will be responsible for successful technology transfer, process validation, and lifecycle management of manufacturing processes. The range of tech transfers may include new product introductions as well as site-to-site transfers. These responsibilities include partner technical assessment, tech transfer and process establishment, initial process oversight (e.g., virtual and as person-in-plant), and performance management. The successful candidate will work closely with other CMC functions to ensure harmonized strategies are executed to ensure right-first-time transfer of our innovative therapeutic clinical products. The right candidate will be highly knowledgeable in protein biochemistry, have a solid technical operations background, and understand the challenges and impact of managing cross-functional partners. A strong understanding of the drug development pathway through commercialization and risk management will be an asset.
Key Responsibilities: Leader and accountable person for technology transfer and process validation activities to receiving sites (internal and external) to assure supply of preclinical and clinical materials which meets quality, compliance, and regulatory requirements as well as the timeline requirements of the program. Lead the on-time, right-first-time and within budget transfer and process validation of manufacturing processes to internal and/or external (CDMO) manufacturing sites in support of Vertex’s cell, gene and biological pipeline products. This could include New Product Introductions as well as site-to-site transfers. Build and maintain technical and business relationships with chosen manufacturing sites and technical teams. Lead a team of direct reports to execute on team goals. Collaborate with sending and receiving site project leaders/coordinators to develop and execute the project plan against an agreed-to budget. Ensure appropriate support for the transfer in terms of documentation, training, technical insight, person-in-plant oversight, and post-transfer performance monitoring. Communicate progress versus plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions. Draft and deliver Regulatory source documents in support of INDs, CTAs, BLAs and other agency correspondence. Where relevant, participate in the manufacturing site selection process by evaluating capabilities against technical requirements. Support the generation, review, execution of statement of work (SOW) documents, corresponding purchase orders, invoicing, and any necessary change orders. Track activities and deliverables relative to budget and company objectives Establish a robust tracking and reporting process to ensure compliance with KPIs, metrics, internal/external audit observation deadlines or other regulatory commitments. Deliver against objectives and priorities in close coordination with CMC team, clinical operations, supply chain planning and other functions as needed.

Requirements

• BS/BA in relevant scientific/engineering discipline (e.g., engineering, natural or life sciences) with 15+ years of relevant experience in biotech or pharmaceutical industries, or PhD degree with 11+ years of relevant experience, ideally including technical leadership within the biotechnology industry.
• Strong technical background in biologics and/or cell and genetic therapies.
• High level of skill and experience with key bioprocess unit operations including: cell culture, cell line development, bioreactor operation and scale-up, column chromatography (size-exclusion, affinity, ion-exchange), tangential flow and normal flow filtration, final formulation/fill-finish.
• Extensive experience in the successful technology transfer of complex processes and methods to internal/external receiving sites.
• Extensive experience in process validation with demonstrated success in Process Performance Qualification (PPQ) campaigns
• Advanced knowledge of GMP practices and regulatory requirements from FDA and other global health authorities.
• Demonstrated ability to lead teams and complete tech transfers and PPQs in a highly matrixed organization.
• Strong leadership skills and an innate ability to collaborate and build relationships.
• Solid experience managing complex projects.
• Excellent written and verbal communication skills, with an ability to communicate clearly and concisely to key stakeholders and influence senior management both internally and externally.
• Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
• Must be goal oriented, quality conscientious, and customer focused.
• Able to travel, domestic and international, up to 20% of time.

Responsibilities

• Leader and accountable person for technology transfer and process validation activities to receiving sites (internal and external) to assure supply of preclinical and clinical materials which meets quality, compliance, and regulatory requirements as well as the timeline requirements of the program.
• Lead the on-time, right-first-time and within budget transfer and process validation of manufacturing processes to internal and/or external (CDMO) manufacturing sites in support of Vertex’s cell, gene and biological pipeline products.
• Build and maintain technical and business relationships with chosen manufacturing sites and technical teams.
• Lead a team of direct reports to execute on team goals.
• Collaborate with sending and receiving site project leaders/coordinators to develop and execute the project plan against an agreed-to budget.
• Ensure appropriate support for the transfer in terms of documentation, training, technical insight, person-in-plant oversight, and post-transfer performance monitoring.
• Communicate progress versus plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions.
• Draft and deliver Regulatory source documents in support of INDs, CTAs, BLAs and other agency correspondence.
• Where relevant, participate in the manufacturing site selection process by evaluating capabilities against technical requirements.
• Support the generation, review, execution of statement of work (SOW) documents, corresponding purchase orders, invoicing, and any necessary change orders.
• Track activities and deliverables relative to budget and company objectives
• Establish a robust tracking and reporting process to ensure compliance with KPIs, metrics, internal/external audit observation deadlines or other regulatory commitments.
• Deliver against objectives and priorities in close coordination with CMC team, clinical operations, supply chain planning and other functions as needed.

Benefits

• annual bonus
• annual equity awards
• medical, dental and vision benefits
• 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)
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director