Scientist, Drug Product 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 (iPSCs) 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 differentiates Century from other approaches that utilize non-renewable donor-derived cells.

Role

Century Therapeutics is seeking a scientist who is self-motivated, innovative, and results-oriented to lead the drug product formulation development of cell therapy products. The candidate will primarily work on evaluating and developing formulations and process protocols across Century's cell therapy pipelines for both intermediate cells and final drug product. The candidate will apply fundamental cell biology principles to conduct formulation screening, while applying appropriate analytical characterization tools to assess cell quality and stability attributes. They will independently design studies with the goal of implementing product enhancement across various Century platforms. The candidate will work with multiple teams including Process Development, Analytical Development, Research, Regulatory, etc.

Responsibilities:

• Design and execute key experimental studies on formulation, and cryopreservation of candidate cell therapy product
• Assess and identify cryopreservation Critical Process Parameters (CPPs) for both intermediate cells and final cell products with different drug product presentations.
• Establish analytical approaches to employ during formulation screening, including but not limited to cell health, membrane integrity assays, molecular mechanism indicator assays, cell-specific functional assays, etc.
• Develop high-throughput methods for screening (including freezing and post-thaw analysis)
• Lead studies to define clinical preparation and administration procedures
• Author and review technical reports detailing experimental work and summarizing results for QA and Regulatory filings

Qualifications:

• PhD in Biology, Bioengineering, or Biomedical Engineering or related disciplines with 0-3 years of relevant post-doc or industry experience
• Working knowledge in formulation, and process development for cellular drug products, strong understanding of cell biology (/cryobiology)
• Demonstrated ability to lead research projects to develop/implement novel strategies to improve drug delivery systems/formulation/cell therapy systems
• Experience with cell viability and functionality assays
• Proficiency in aseptic techniques and mammalian cell culture
• Innovative mindset with strong interest in Drug Product Development
• Sound knowledge in DOE with proficiency in statistical software such as JMP or Minitab
• Clearly communication of results to stakeholders (written and oral presentation skills)
• Works effectively in cross functional teams and projects

Century Therapeutics Inc. is an Equal Employment Opportunity/Affirmative Action Employer - Minority/Female/Disability/Veteran. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status or any other characteristic protected by federal, state, or local law.