Engineer/Sr. Engineer, Process Development

Location
Philadelphia, PA, United States
Posted
Oct 08, 2021
Ref
2741522569
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Position Title: Engineer / Senior Engineer, Process Development

Company Background

Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of current cell therapies. Century's genetically-engineered, universal iPSC-derived immune effector cell products are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care.

Century's foundational technology is built on induced pluripotent stem cells (iPSC) that have unlimited self-renewing capacity. This enables complex cellular engineering to produce controlled cell banks of modified cells that can be expanded and differentiated into desired immune effector cells, which can supply vast amounts of allogeneic, homogeneous therapeutic products. This platform distinguishes Century's from other approaches that utilize non-renewable, donor-derived cells.

Role:

The Process Development Engineer will be responsible for the development of manufacturing processes for Century's cellular therapy programs. The successful candidate will lead a team accountable for process scale-up and scale-out, translating the promise allogeneic stem cell technologies into clinical and commercial products, and technology transfer to internal and external stakeholders. This candidate will be tasked with unit operation development, process optimizations which result in the development on new production platforms for cGMP manufacturing.

This role is based in Philadelphia (University City), PA.

Responsibilities:
  • Lead, mentor and train a small team toward early-stage process scale-up. Providing effective leadership including individual performance goal setting, managing the process scale-up team, responsible for motivating members and recognizing employee contributions
  • Identify and critically assess opportunities to improve cell therapy platform, such as manufacturing of CAR-natural killer cells and other cell products derived from induced pluripotent stem cells.
  • Act as a subject matter expert in the allogeneic cell therapy process development team
  • Collaborate with internal and external members of the manufacturing.
  • Author and review technical documents (batch records, SOPs, reports, memos, etc.)
  • Support tech transfer activities of processes to internal and external sites
  • Author and review CMC documents for regulatory filings (e.g. IND, BLA) in collaboration with other parts of organization
  • Foster a collaborative and scientifically rigorous team culture


Qualifications:
  • PhD in biological, technical, or cell engineering field with no/limited post-doc/industry experience, or BS/MS degree with 10-12 years for BS or 7-10 years for MS of relevant professional experience


Requirements:
  • Experience in design, optimization, scale-up, process control, and/or technology transfer of cell culture unit operations.
  • Hands-on experience with analytical methods typically used in the manufacture and characterization of cell therapies or biological products
  • Mammalian cell culture using closed system and automated/dynamic technologies
  • Proficiency with statistical methods for data analysis (e.g., JMP, GraphPad Prism)