Title: Director, Drug Product Manufacturing
Location: Boston, MA
Summary: A rapidly growing BioPharma company is seeking a driven, and motivated Director of Drug Product Manufacturing to help lead the TechOps team in Boston, MA. You will play a key role in the process development and clinical manufacturing of drug product at the CMO, while providing technical transfer support alongside the MSAT team. You will also work cross functionally to prepare for pre validation activities and identify gaps in the manufacturing process.
The Director will have these Key Responsibilities:
- Manage relationships with CMOs and CROs; engage with CDMOS to support GMP manufacturing
- Serve as Person in Plant at CMOs; Deliver commercial and clinical drug supply commitments to both internal and external stakeholders
- Write and review technical documentation, including batch records and reports for regulatory filings
- Partner with the MSAT team to drive technology transfer, scale-up of process improvements, and vaccine manufacturing development at the CMOs
- Develop project plans and schedules to ensure timely delivery of cGMP products
- Effectively communicate technical information and project progress to Senior leaders and partners
The Director will have the following qualifications:
- MS in engineering or relevant field, and 10+ years of vaccine manufacturing experience required
- Experience with Process Development and GMP manufacturing at CDMOs required
- Thorough understanding of analytical development, drug product formulation, and technology transfer within a cGMP environment
- Must have extensive team leadership, coaching, and problem-solving experience
- Willingness to travel up to 5-10% as required to CMO, CRO, and key vendors
Benefits/Perks:
This company offers a competitive and flexible benefit plan, along with a focus on your well-being, which will allow you to have a healthy work-life balance.
- Annual bonus
- Generous paid time off, wellness offerings, and more
- Career development opportunities, internal growth