Director, Process Engineering

Location
Philadelphia, PA, United States
Posted
Feb 20, 2021
Ref
2419636206
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Title: Director, Process Engineering

Reports to: Sr. Director, Process & Product Development

Department Name: Technical Development & Manufacturing

JOB DESCRIPTION:

Century Therapeutics is harnessing the power of adult stem cells to develop allogeneic cancer therapies. The Director, Process Engineering will utilize their experience and knowledge to design and execute R&D activities focused on mammalian cell culture technologies, with a focus on process scale-up and technology transfer. Key responsibilities include, but are not limited to, the development, characterization/validation, and transfer of cell therapy manufacturing processes (including ancillary materials) to GMP facilities. The ideal candidate will serve as a subject matter expert, design and execute lab experiments toward manufacturing process optimization, provide operational support to internal and external partners, draft regulatory submissions, and lead a team of up to 5 process engineers.

Responsibilities:
  • Develop and implement manufacturing processes capable of supplying clinical trials with material compliant of product quality targets, current Good Manufacturing Practices (cGMP), and regulatory requirements
  • Support the delivery of engineered immune cell therapies e.g., draft regulatory submissions, lead and/or serve as functional representative on project teams
  • Identify novel solutions to address key technical challenges required for manufacturing platform success, such as cell culture media optimization, cell harvest, process scale-up
  • Outline experimental strategy toward at-scale cell differentiation, expansion and harvest capabilities
  • Collaborate with external partners to transfer stem cell process technology and optimize Century's next-generation manufacturing process
  • Define scientific agenda and manage research activities of junior lab members and interns/co-ops
  • Maintain laboratory procedures, systems and notebooks, to ensure documentation of research activities
  • Domestic travel up to 25%


Qualifications:
  • PhD in biochemistry, biochemical engineering, or a relevant technical, life sciences field, with a minimum of 10 years of industry experience. BS/MS with a minimum of 13 years of relevant experience


Requirements:
  • Proven track record in bioprocess development e.g., cellular therapies, recombinant proteins, and/or vaccines
  • Depth of experience in mammalian cell culture media optimization, process scale-up/down and characterization, bioreactor design, cell harvest unit operations, technology transfer
  • Functional experience in mammalian cell culture process development, including molecular biology, cell harvest, and aseptic techniques
  • Understanding of bioprocess characterization/validation and technology transfer concepts, such as cGxPs and CMC regulatory requirements
  • Ability to manage and deliver high-profile projects, and to transform corporate objectives into team goals
  • Understanding of cell biology/physiology and/or engineering fundamentals. Experience with induced pluripotent stem cells (iPSC) is highly desirable
  • Equipment development and qualification in cGMP environment e.g., IQ/OQ/PQ
  • Experience with regulatory submissions e.g., IND, BLA
  • Dynamic and culturally astute team-player, scientifically rigorous with excellent communication skills
  • Demonstrated technical team leadership ability


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