Associate Director/Director, Analytical Science and Technology

Location
Branchburg, NJ
Posted
Jun 02, 2021
Ref
2540034737
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:

The Associate Director / Director, Analytical Science and Technology is accountable for providing strategic and scientific guidance to the analytical team responsible for method transfers, method improvements and remediation, method validations, and troubleshooting for clinical products within the quality control laboratories. Additionally, this group leader will oversee the selection of analytical technologies and development of a comprehensive product and process characterization strategy 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 Branchburg, NJ.

 

Responsibilities:

  • Lead a group of scientists and oversee method transfers, method improvements and remediation, method validations, and troubleshooting for clinical products
  • Working in close collaboration with Project Management, serve as the analytical project leader on the Early Development Team for assigned programs
  • Implement state-of-the-art technologies and compliant, phase-appropriate methods in support of product and process characterization, comparability, and quality control activities
  • Lead product and process characterization and comparability activities
  • Monitor and manage the life cycle of analytical methods for clinical products
  • Manage analytical method review and approval, performance trending, improvement/ remediation, method versioning and specifications change control in quality systems
  • Support QC method investigations to identify root cause
  • Author, review and approve technical documents such as methods, qualification and validation protocols and reports in collaboration with QC
  • Lead preparation of CMC documents for regulatory filings
  • 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:

  • Demonstrated ability to develop, validate, and transfer analytical procedures for use in quality control (release and stability) applications with emphasis on cell-based potency methods, cellular characterization, flow cytometry, and molecular methods (qPCR, digital PCR)
  • Experience with product and process characterization, specifically in support of comparability assessments
  • Knowledge of applicable CMC regulatory guidance
  • Experience writing and reviewing regulatory submissions
  • Experience leading scientific teams, including direct people management
  • Excellent technical, communication, writing, and project management skills