Scientist or Senior Scientist, Drug Product Development (Formulation)

Position Title: Scientist or Senior Scientist, Drug Product Development (Formulation)

Reports to: Associate Director, 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 formulation development of cell therapy products. The candidate will primarily work on evaluating and developing cryopreservation formulations and process protocols across Century's cell therapy pipelines for both intermediate cells and final drug product using an array of high throughput and sensitive analytical techniques. The candidate will apply fundamental cell biology principles to conduct formulation screening, while applying appropriate techniques to characterization cell quality and stability attributes. They will independently design studies with the goal of implementing product enhancement across various Century platforms. The candidate will be part of a cross-functional matrix and work closely with PD and other internal CMC partners including R&D, AD, QC and QA.

This role is based in Philadelphia, PA (TBDT61)

Responsibilities:

• Design and lead the screening of novel cryopreservation formulations to meet the requirement per Target Product Profiles (TPPs).
• Assess and identify cryopreservation Critical Process Parameters (CPPs) for both intermediate cells and final cell products with different drug product presentations.
• Design, perform and analyze experiments and results to delineate impacting factors and their interactions using Design of Experiment (DOE) and other statistics for cell cryopreservation.
• Collaborate and work towards establishing analytical approaches to support cryopreservation development, including but not limited to cell health, membrane integrity assays, molecular mechanism indicator assays, cell-specific functional assays, and proteomics/genomics assays.
• Explore and investigate novel solutions, materials, and platforms to meet cell cryopreservation challenges for different iPSC-derived drug products.
• Lead and plan studies to define post-thaw drug product handling, and Pharmacy Manual studies.
• Author and review technical reports detailing experimental work and summarizing results for QA and Regulatory filings.

Qualifications:

• PhD in Biology, Bioengineering, or Biomedical Engineering disciplines with 1-3 years of relevant post-doc or industry experience.

Requirements:

• Working knowledge and demonstrated proficiency in cellular cryobiology, and/or formulation and process development for cellular drug products.
• Demonstrated ability to lead research projects to develop/implement novel strategies to improve drug delivery systems/formulation/cell therapy systems.
• Attention to detail and accuracy, ability to think critically, and work in a fast-paced setting to meet deadlines and prioritize across multiple projects/platforms.
• Proficiency in aseptic techniques and mammalian cell culture.
• Sound knowledge in DOE with proficiency in statistical software such as JMP or Minitab.
• Clearly communicates ideas and 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.