Generate Biomedicines, Inc. is a Flagship backed, privately-held biotechnology company on a mission to reimagine the drug discovery process to one of deterministic, data-driven generation. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. Generate will be successful by constantly turning innovative ideas into methods, technologies, and therapeutics that solve some of the most difficult challenges with developing medicines. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!
Generate was founded by Flagship Pioneering. Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $30 billion in aggregate value. The current Flagship ecosystem comprises 37 transformative companies, including: Moderna Therapeutics (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Indigo Agriculture, and Sana Biotechnology.
Generate is seeking a highly experienced and innovative Head of Process Development and Manufacturing (PDM) to join our growing team. She/he will be responsible for defining the process development and manufacturing strategy, building these capabilities in-house while also managing external CMO/CDMO relationships, and for executing the process development and manufacturing on unpartnered programs. The ideal candidate will have a proven track record in managing process development/CMC-related activities of antibodies and other biologics. She/he will also be expected to work closely with our machine-learning and data scientists to continuously optimize this process.
- Lead teams of directors, managers and technical professionals working in the different areas of Process Sciences (PS)
- Oversee PS laboratories in Massachusetts; ensure operations are safe and efficiently managed.
- Hire and develop employees within the department in support of multi-site objectives. Assign work, provide feedback and coaching, shifting priorities and resources, as needed.
- Provide technical leadership to process engineers, scientists, and associates in the PS laboratories for clinical and commercial stage products.
- Coordinate technology transfers and training (from clients, and within and to/from other partners) to ensure effective information flow, timeline execution, issue resolution, and documentation for cross-functional teams.
- Make decisions based on the professional judgment, sound scientific and engineering practices, experience, budget, cGMP regulations, and the ethical guidelines of good business practices.
- Communicate progress regularly to CSO and broader Leadership Team.
- Represent Process Sciences /CMC teams on Project Teams and governance reviews to coordinate multi-functional activities for clinical and commercial programs.
- Develop the PS strategy, program timelines, and budgets.
- Stay current with relevant technologies and forward thinking to identify new approaches and implement as appropriate.
- PhD in Scientific and/or Engineering discipline
- Minimum of 15 years of experience in a biologics process development and manufacturing at a life sciences GMP/FDA regulated company (Biotech/Pharma)
- Minimum of 10 years of experience in a biologics process development and manufacturing management at a life sciences GMP/FDA regulated company (Biotech/Pharma)
- Significant GMP/cGMP experience
- Evidence of creativity in addressing challenging process development manufacturing approaches
- Prior experience in technical transfers, qualification, validation, trouble shooting, FDA inspections, process scale-up, and commercial operations support
- Demonstrated leadership skills with proven ability to create and grow high performing manufacturing teams
- Strong understanding of budgeting/expense management including financial and accounting practices
- Track record in deploying commercial components into high-volume production with fast time-to-market and cost-sensitivity requirements
- Excellent communication, documentation and technical writing skills
- Familiarity of regulatory issues pertaining to the manufacture of biologics, large-scale biopharmaceutical unit operations and process validation