Lead, Large-Scale Cell Therapy Process Development

Century Therapeutics, Inc; Branchburg Township (NJ); On-site; USD 195,000 - 218,000; Full time

Benefits offered by this job

Performance-based bonus

Medical, dental, and vision insurance

401K with company matching

20+ days PTO

Job summary

Century Therapeutics, Inc. is seeking a Director of Large Scale Process Development in Branchburg, NJ to lead scale-up strategies for bioreactor expansion, harvesting, and fill/finish processes across clinical and commercial programs.

The role drives GMP-compliant, cost-effective production, mentors a team of process development scientists, and partners with MSAT, Regulatory, and Manufacturing to transfer processes into manufacturing and support regulatory submissions.

Qualifications

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

Responsibilities

• Lead all efforts related to scale up of cell processes for clinical and commercial manufacturing.
• Provide strategic and scientific leadership to a team of process development scientists and engineers.
• Oversee execution of scale up and scale-down experiments for cell expansion, differentiation, harvesting, and fill/finish.
• Serve as process development lead in mid to late-stage development programs to meet corporate objectives.
• Foster growth of scale-up capabilities and adoption of advanced technologies and tools.
• Collaborate with MSAT and Manufacturing to tech transfer processes into manufacturing.
• Act as SME during GMP manufacturing and perform GMP activities as needed.
• Lead authoring and internal review of regulatory submissions and support IND/CTA/IMPD/CTN related to clinical studies.
• Communicate scientific data via presentations, protocols, and reports; participate in external publications.
• Manage staffing, scheduling, and laboratory activities to meet objectives and budgets.
• Provide mentorship and contribute to a collaborative, high-performance culture.

Skills

Leadership

Scale-up

GMP manufacturing

Process development

Bioreactor processes

Cross-functional leadership

Education

BS/MS/PhD in Biomedical/ Chemical/ Biotechnology

Job description

Century Therapeutics, Inc. is seeking a Director of Large Scale Process Development in Branchburg, NJ to lead scale-up strategies for bioreactor expansion, harvesting, and fill/finish processes across clinical and commercial programs.

The role drives GMP-compliant, cost-effective production, mentors a team of process development scientists, and partners with MSAT, Regulatory, and Manufacturing to transfer processes into manufacturing and support regulatory submissions.