Our clinical stage Vaccine client located in Boston, MA is looking to add an Associate Director/Director, Drug Product Development & Manufacturing to their team! This position will have responsibility for providing scientific thought and technical leadership at the Contract Manufacturing Organization (CMO) for process development and clinical manufacturing of drug product while actively collaborating with the MSAT team to support technical transfer of drug product manufacturing process into GMP Manufacturing. This individual will work with a cross functional team across Tech Ops, including CMC Development, MSAT, Supply Chain, and Analytical Development teams to identify gaps and add manufacturing robustness for preparation of pre validation activities. 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.
- Provide scientific and technical leadership, manage relationships with CMOs, CROs and key suppliers including coordination, communication, and technical oversight, to ensure timely delivery of cGMP products to support clinical trials.
- Serve as a technical and operational point of contact to the CMOs to perform gap analysis, manage drug product development studies, mixing and hold time studies, scale up risk assessments and small-scale stability studies to support drug product development and fill finish operations.
- Actively engage with CDMOs to support and manage GMP batch manufacture and testing, support deviation investigations, batch review and release of GMP material.
- Drive generation of Manufacturing Batch records and sampling plans in collaboration with the CDMO teams. Review and approve all manufacturing related GMP documents.
- Collaborate with Project Management and CMOs in developing project plans and schedules and ensure that tasks are executed according to the operational plans, Development & Master Services Agreement, cGMP requirements and regulatory commitments.
- Actively partner with MSAT team to drive vaccine manufacturing development, technology transfer and scale-up of process improvements as required at the CMOs.
- Drive preparation, review, and approval of CMC sections of regulatory filings, be the point of contact for interfacing with the regulatory agencies.
- 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.
- Communicate technical information and project progress to the Senior leadership and external partners.
- Liaise and work with 3rd party CROs for timely release testing of the GMP batches
- Travel as required to CMO, CRO and key vendor for Manufacturing oversight and partnership for product development purposes.
- Partner with key functions including Quality, Project Management, Clinical Operations, Finance and Regulatory Affairs.
- MSc or PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 10 years in the vaccine manufacturing environment
- Thorough understanding of technical areas related to processes, unit operations and functions involved in vaccines drug product development and manufacturing
- Technical experience with prefilled syringes and sterile injectables is highly desirable
- Direct experience in leading process development and GMP manufacturing activities at the CDMOs.
- Demonstrated ability to work effectively in a team-oriented CMC environment.
- Proven experience in managing and coordinating both internal and external deliverables.
- Well-developed knowledge of cGMP practices as applicable to technology transfer, manufacturing, drug product 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.
- Proven experience in a matrix environment is preferred.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Up to 5-10%.