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.
Qualifications:
- 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.
Required/Preferred Skills:
- 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.
Benefits:
- Annual performance-based bonus; medical/dental/vision insurance; 401(k) match; 20+ days PTO.
Compensation:
- Expected annual salary range: $195,000β$218,000.
Application instructions:
- Not accepting unsolicited resumes from search or staffing firms without a valid written search agreement.