Associate Director/Director, Analytical Development

Location
Philadelphia, PA, United States
Posted
Jul 17, 2021
Ref
2543838519
Hotbed
Pharm Country
Required Education
Bachelors Degree
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:

The Associate Director / Director, Analytical Development is accountable for providing strategic and scientific guidance to the analytical team responsible for developing Century's quality control and characterization platform. With a focus on scientific and technical excellence, this group leader will oversee the selection of analytical technologies, establishment of analytical procedures, and the validation and transfer of methods in support of early development programs. This role will interact extensively with internal and external partners to advance pipeline programs through key CMC milestones.

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

Responsibilities
  • Lead a group of scientists to perform analytical method development, optimization, and validation under cGMP in collaboration with Quality Control
  • Develop the quality control and characterization platform strategy for Century's pipeline of genetically-engineered, iPSC-derived cell therapy products
  • Serve as subject matter expert for cell-based potency methods, flow cytometry, and molecular assays
  • Implement state-of-the-art technologies and compliant, phase-appropriate methods in support of product and process characterization, comparability, and quality control activities
  • Author, review and approve technical documents such as methods, qualification and validation protocols and reports in collaboration with QC
  • Ensure systems, processes, and resources are in place to conduct laboratory activities in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, and OSHA safety standards

Qualifications:
  • Ph.D. in Biochemistry, Cell Biology, Molecular Biology, Biotechnology, Biological Sciences or related discipline
  • At least 10+ years relevant experience in biopharmaceutical assay development, with minimum 3 years in a managerial capacity


Requirements:
  • In-depth experience in analytical development with emphasis on cell-based potency methods, cellular characterization, flow cytometry, and molecular methods (qPCR, digital PCR)
  • Demonstrated ability to develop, validate, and transfer analytical procedures for use in quality control (release and stability) applications
  • Experience writing and reviewing regulatory submissions
  • Experience leading scientific teams, including direct people management
  • Excellent technical, communication, writing, and project management skills

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