Our Vaccine client located in Boston, MA is looking to hire a Director, Purification Process Development to their Tech Ops team! The Downstream process development leader to lead, manage and support technical transfer and clinical manufacturing of GMP supplies at various contract manufacturing sites. This position will have primary responsibility for scientific leadership and technical oversight of the technical transfer, GMP readiness and ensuring process robustness of clinical supplies manufactured at the Contract Manufacturing Organization (CMO). This individual will work with a cross functional team across Tech Ops, including CMC Development, MSAT, Supply Chain, and Analytical Development teams. They will be a member of the core program team representing Tech Ops and will partner with other leaders to drive and lead implementation of CMC project strategies and comprehensive project plans at the CMOs.
The Director, Downstream operations will also expand technical capabilities through evaluation and development of new manufacturing processes, FMEA analysis, root cause investigations and data analytics in conjunction with cross functional teams within the organization to improve process robustness.
Experience with clinical process development phases, cGMP operations, and regulatory expectations is essential for success. Chromatography scale-up and development experience is strongly desired, including understanding of the underlying engineering principles.
- Provide scientific and technical leadership, manage relationships with CMOs, CROs and key suppliers including coordination, communication and technical oversight, to ensure successful process transfer, GMP readiness and timely delivery of cGMP products to support clinical trials.
- Oversee experimental, tech transfer, and manufacturing support activities devoted to advancing clinical stage CMC programs.
- Serve as primary technical point of contact to the CMOs to drive tech transfer, gap assessments, FMEA analysis and implementation of mitigation plans to derisk GMP batches.
- Support deviation investigation, development of product specifications and sampling plans. Review and approve all manufacturing related GMP documents.
- Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness.
- Identify and lead additional development activities and manufacturing through various phases of product development.
- Participate in efforts to define, manage, and/or complete innovation projects that advance technical capabilities, refine & establish platform manufacturing processes.
- Track team progress against project timelines, generate regular status updates and communicate progress, resourcing needs and issues to leadership.
- Generate documentation for experimental reports to support technology transfer and regulatory filings (development and technical report writing).
- Partner with key functions including Quality, Project Management, Clinical Operations, Finance and Regulatory Affairs.
- Communicate technical information and project progress to the Senior leadership and external partners.
- PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 8 years in the bio/pharmaceutical manufacturing environment. MS/BS with 10+ years of relevant experience in MSAT or process development of biologics /vaccines may also be considered.
- Direct experience in leading development, tech transfer and GMP manufacturing activities with CMOs is necessary.
- Technical expertise in development and full-scale manufacture of recombinant biologic products. Direct experience in Vaccine development and Phase 3 readiness support is highly desirable.
- Proven experience in managing and coordinating both internal and external deliverables.
- Well-developed knowledge of cGMP practices as applicable to technology transfer, manufacturing, formulation, and analytical development.
- Proficiency in statistical software for data analysis and tracking and trending.
- Established external network of service providers, technical experts, suppliers, and technology providers.
- Seeking Boston local candidates to be on-site 2-3 days per week.
- Travel as required to CMO, CRO and key vendor for Manufacturing oversight and partnership for product development purposes. (Up to 5-10%.)