Scientist or Senior Scientist, Cryobiology

Location
Philadelphia, PA
Posted
Jun 02, 2021
Ref
2532256847
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time

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/Senior Scientist who is self-motivated, innovative, and results-oriented to lead the formulation and cryobiology efforts. The successful candidate will serve as a subject matter expert for formulation, cryopreservation, storage and assessment of drug product stability. They will independently design, execute, and analyze experiments to drive novel cryopreservation solutions for various Century platforms.

 

The Scientist/Senior Scientist will be part of the Process & Product Development team with primarily focus on formulation development, but also support aseptic fill-finish development, scale-up of cryopreservation protocols, and pharmacy manual studies.

 

Responsibilities:

The Drug Product Scientist will play a key role in the development and implementation of cryo-formulation strategies across Century’s early-phase cell therapy portfolio. The position will require strong technical and experimental skills, innovative-thinking, collaborative teamwork across cross-functional groups and clear organization. Primary responsibilities include development and optimization of drug product formulations and optimization of cryopreservation protocols, as well as execution and characterization of the other cell therapy fill/finish process steps. 

The successful candidate will develop strong relationships with internal and external partners, including but not limited to Process Development, Manufacturing, Regulatory, and Clinical functions. In addition, the candidate will work with the CMC team to provide technical support for regulatory (IND) submissions.

 

Candidate responsibilities will include (but not limited to) the below: 

  • Provide subject matter expertise across the organization in the field of cryobiology. Up-to-date and well versed in scientific literature pertaining to drug product formulations and cryopreservation strategies
  • Identify and implement novel formulations for improved cryopreservation and cell health properties. Scope of formulation work will include impact on drug product short-term and long-term stability
  • Evaluate new technologies as part of formulation development work, freezing, storage, shipping and thawing of cell therapy products
  • Able to identify root cause of cryopreservation and formulation issues, and provide actionable feedback to improve protocols/processes
  • Present findings to key functional leads in the CMC team

 

Qualifications:

  • PhD in biological, technical, or engineering field and 2-6 years of post-doc/industry experience. Or MS degree in a relevant biological, technical, or engineering field with 7-10 years for MS, of relevant professional experience.

 

Requirements:

  • Demonstrated ability to lead complex research projects to develop/implement novel strategies to improve cell cryopreservation
  • 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
  • Expertise in statistical experiment design (DOE) with proficiency in statistical software such as JMP or Minitab
  • Proficient with conventional lab equipment used for cryopreservation of biological material as well as common analytical techniques used in assessing cryogenic and biological performance. Analytical experience (preferred) in cell-based assays including viability, assessment of phenotype by flow cytometry, and other appropriate analytics to support cryopreservation efforts
  • Clearly communicates ideas and results to stakeholders (writing and oral presentation skills)
  • Works effectively in cross functional teams and projects
  • Understanding of regulated manufacturing environments, i.e. aseptic and GMP production.

 

Keywords:

Cryopreservation, cryobiology, formulation, drug product development, cell therapy, fill finish, aseptic