Director, Large Scale Process Development

Century Therapeutics•Branchburg, NJ

4d•Onsite

About The Position

The Director, Large Scale Process Development, is accountable for all scale up strategies, methodologies, and experiments that support the advancement of Century’s product portfolio with the goal of developing and implementing cost-effective, productive, GMP-compliant, and large capacity processes for clinical and commercial manufacturing. This development includes bioreactor processes for cell expansion and differentiation, centrifugation and filtration processes for cell harvesting and isolation, and container filling for intermediate and final product presentation. This dynamic, scientifically motivated, operationally-savvy and highly collaborative individual will be a key leader and voice influencing critical areas of the technical development and operations organization and play an important role in collaboration with Research, Regulatory, Analytical and Manufacturing teams. This role is based in Branchburg, NJ, which is the location of our GMP manufacturing facility and our process development and analytical development teams. The work expectation for this role is 5 days per-week on-site.

Requirements

BS, MS or Ph.D. in Biomedical Engineering, Chemical Engineering, Biotechnology, Biological Sciences, or related discipline.
PhD with at least 10 years relevant experience or BS or MS with at least 15 years relevant experience in biopharmaceutical or cell therapy process development, scale-up, tech transfer and GMP manufacturing.
Demonstrated experience in process scale-up, particularly cell therapy process scale-up, process development, process optimization, tech transfer, and GMP manufacturing.
Technical excellence in scale-up engineering principles, theory and practical application.
Sound understanding of, and the ability to interpret, GMPs for the production of clinical products.
Ability to read, write and interpret technical and quality documents, such as batch production records, standard operating procedures (SOPs), change requisitions, non-conformances, and corrective action plans (CAPAs).
Demonstrated leadership skills, including the ability to manage scientific teams; work effectively within a matrix team; communicate, coach, and mentor employees.
Strong scientific reasoning, problem-solving, and technical skills in process development, scale-up, cell culture, cell isolation, filling and GMP manufacturing.

Responsibilities

Lead all efforts related to scale up of Century’s cell processes, with the goal of implementation in clinical and commercial manufacturing.
Provide strategic, technical, and scientific leadership to a team of process development scientists and engineers, with responsibility for overall strategy and direction.
Oversee execution of scale up and scale-down experiments for cell expansion and differentiation, cell harvesting, and intermediate and final drug product container filling.
Function as a process development lead in mid to late-stage development programs to deliver on corporate objectives related to the advancement of the company’s pipeline programs.
Foster the growth of scale-up capabilities, including the implementation of state-of-the-art technologies, computational tools, and engineering principles in support of process scale-up, development, characterization, validation, tech transfer and GMP implementation.
Collaborate with other process development groups, MSAT and Manufacturing teams to tech transfer processes into clinical and commercial manufacturing.
Along with his/her team members, act as subject matter experts during the GMP manufacturing of our products, including side by side execution of GMP activities as necessary.
Lead authoring and internal review of regulatory submissions and engage in dialogue with health authorities supporting regulatory review of IND/CTA/IMPD/CTN applications for first-in-human clinical studies and associated internal source documents.
Communicate scientific data and information effectively through presentations, protocols, and reports, and where appropriate, through external presentation/publication in scientific, technical, and investor forums.
Responsible for resourcing, scheduling, and coordinating laboratory activities to meet organization objectives.
Estimate, report, and manage to a departmental budget.
Provide mentorship and guidance to his/her team members as well as additional team members and contribute to establishing and growing a strong, engaged culture within technical development, built on scientific competency and technical excellence, collaboration, and effective communication.