Director, Scale Process Development

Role:
Director, Large Scale Process Development (Branchburg, NJ; 5 days/week on-site)
Responsibilities:

• Lead all scale-up efforts for cell processes for implementation in clinical and commercial manufacturing.
• Provide strategic, technical, and scientific leadership to a team of process development scientists and engineers.
• Oversee scale-up/scale-down experiments for cell expansion and differentiation, cell harvesting, and intermediate/final drug product container filling.
• Serve as process development lead in mid to late-stage development programs.
• Build scale-up capabilities by implementing state-of-the-art technologies, computational tools, and engineering principles for scale-up, development, characterization, validation, tech transfer, and GMP implementation.
• Collaborate with process development groups, MSAT, and Manufacturing to tech transfer processes.
• Act as subject matter expert during GMP manufacturing (including side-by-side GMP activities as needed).
• Lead authoring and internal review of regulatory submissions and engage with health authorities for IND/CTA/IMPD/CTN for first-in-human studies.
• Communicate via presentations, protocols, and reports; support external presentations/publication as appropriate.
• Manage resourcing, scheduling, and lab activity coordination; estimate, report, and manage departmental budget.
• Mentor team members and contribute to a strong technical culture.

• BS/MS/PhD in Biomedical Engineering, Chemical Engineering, Biotechnology, Biological Sciences, or related field.
• PhD with 10+ years or BS/MS with 15+ years in biopharmaceutical/cell therapy process development, scale-up, tech transfer, and GMP manufacturing.

• Demonstrated experience in process scale-up (cell therapy), process development/optimization, tech transfer, and GMP manufacturing.
• Technical excellence in scale-up engineering principles.
• Ability to interpret GMPs for clinical product manufacturing.
• Ability to read/write technical and quality documents (batch records, SOPs, change requisitions, non-conformances, CAPAs).
• Leadership skills for scientific teams and matrix environments; ability to coach/mentor.
• Strong scientific reasoning and skills in process development, scale-up, cell culture, cell isolation, filling, and GMP manufacturing.

• Annual performance-based bonus; medical/dental/vision insurance; 401(k) match; 20+ days PTO.

• Expected annual salary range: $,000.