Sr. Associate Scientist/Associate Scientist, Drug Product Development

Location
Philadelphia, PA, United States
Posted
Sep 24, 2021
Ref
2725778419
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Position Title: Sr. Associate Scientist/Associate Scientist, Drug Product Development

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 an Sr. Associate Scientist/Associate Scientist, Drug PD who is self-motivated, innovative, and results-oriented to lead cell therapy development efforts. The successful candidate will conduct drug product development activities including formulation, fill, and finish operations, as well as drug product stability studies. They will design, execute, and analyze experiments across the various Century platforms.

Responsibilities:

The Drug Product Scientist will play a key role in the development and implementation of processes across Century's early-phase cell therapy portfolio. The position will require technical and experimental skills as well as collaborative teamwork across cross-functional teams. Primary responsibilities include development and optimization of drug product formulations for cryopreservation, as well as execution and characterization of the other cell therapy fill/finish process steps.

Candidate responsibilities will include (but not limited to) the below:
  • Execute process development studies using scientific and engineering principles to develop and improve unit operations used for production of cell therapies
  • Conduct cell therapy formulation and drug product stability studies
  • Work as a key team member on shared deliverables to meet project timelines and deliverables
  • Timely and thorough documentation and completion of electronic laboratory notebooks.
  • Author and contribute to reports detailing experimental work and summarizing results, protocols, technical reports, and SOPs
  • Participate in routine lab operations (lab maintenance, safety inspections, etc.) and maintain compliance with all appropriate SOPs for laboratory work, data recording, and laboratory equipment


Qualifications:

BS or MS degree in a relevant biological, technical, or engineering field with 4-6 years for BS degree or 2-4 years for MS degree OR 6-10 years with BS and 4-6 with MS

Requirements:
  • Knowledge of and experience in CAR-T cell therapy and process engineering. Prior hands-on experience with equipment and unit operations typically used in process development and manufacture of cell therapy products is desired
  • Strong scientific acumen with basic understanding of drug product principles
  • Experience with designing, execution, and troubleshooting new protocols and assays
  • Attention to detail, critical analysis of data, and troubleshooting abilities
  • Excellent written and verbal communication skills
  • Experience with Design of Experiment (DOE) approaches and application to process development is a plus
  • Understanding of regulated manufacturing environments, i.e., aseptic and GMP production
  • 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


Key words: formulation, drug product development, process development, cell therapy, aseptic technique