Director, Quality Control

Location
Branchburg, NJ, United States
Posted
Jul 17, 2021
Ref
2613423072
Discipline
Quality, Quality Control
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Position Title: Director, Quality Control

Reports to: Sr. Director, Analytical Development & Quality Control

Department Name: Technical Development & Manufacturing

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 Director, Quality Control will be responsible for establishing and leading Century's quality control function, providing strategic and operational leadership for the evaluation of our allogeneic, cell therapy products. The position will be responsible for the oversight and real-time monitoring of all QC activities in the analytical network. They will interact extensively with internal and external partners to leverage best-in-class expertise and capabilities in cell therapy analytics. Our expectation is that the incumbent will take on team leadership responsibilities as the Quality Control function grows within the next 1-2 years.

This role will be based at our GMP facility in Branchburg, NJ.

Responsibilities:
  • Lead the quality control function with hands-on work to instruct and build expertise internally and at CDMO laboratories
  • Oversee QC activities (e.g. release, stability, and ancillary material/excipient testing; critical reagent qualification and management), serving as the primary representative and liaison for external laboratories and regulatory agencies
  • Establish new internal QC laboratories, including aspects related to facilities, instruments, processes, and procedures
  • Ensure QC staff are adequately trained and performing tests in compliance with established procedures
  • Serve as an interface to the internal Assay Development function and ensure development of robust and transferable assays into QC laboratories
  • Lead the transfer of new methods into QC laboratories and execution of validation studies, ensuring adequate documentation and controls are in place
  • Participate in the preparation of CMC regulatory submissions and associated Health Authority interactions (e.g., pre-approval inspections).
  • Domestic travel up to 25%


Qualifications:
  • MSc (PhD highly desirable) in biochemistry, biochemical engineering, or a relevant technical, life sciences field, with a minimum of 10 years of QC experience
  • Strong ability to present data in a variety of team settings and actively participate in departmental meetings as well as cross-functional area project teams
  • Ability to excel in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all internal and external stakeholders


Requirements:
  • Minimum 10 years of experience in Quality Control or related analytical support organization
  • Experience with test methods used for cell therapy or biological in-process, release and stability testing, and managing QC laboratories
  • Ability to manage and deliver high-profile projects, and to transform corporate objectives into team goals
  • Outstanding interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations


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