Quality Control Manager, Raw Materials and Critical Reagents

Location
Philadelphia, PA, United States
Posted
Apr 07, 2021
Ref
2478352060
Hotbed
Pharm Country
Required Education
Other
Position Type
Full time
Position Title: QC Manager, Raw Materials and Critical Reagents

Reports to: Director, Quality Control

Department Name: Technical Development and 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:

Century is looking for motivated scientists to advance the growing and promising field of cell therapy to treat cancer. The QC Manager will be part of the Quality Control operations team that will collaborate with Century's Research, Development, and Manufacturing teams towards the development of curative therapies for cancer. As a technical expert with cGMP pharmaceutical experience, the successful candidate will coordinate the planning, sourcing, qualifying, and inventory control of raw materials, reference standards, and critical reagents. The ideal candidate will collaborate with members of various functional groups to achieve company-aligned goals.

This role can be based in either Philadelphia (University City), PA or Branchburg, NJ.

Responsibilities:
  • In collaboration with research, process and analytical development, QC laboratory, and manufacturing teams, plan and perform phase-appropriate risk assessments for proposed raw materials, reference standards, and critical reagents
  • Work with internal stakeholders and material suppliers to establish master service agreements and quality agreements, as well as statements of work and purchase orders for material needs
  • Establish material qualification mitigation strategies and specifications for GMP raw materials, reference standards, and critical reagents
  • Develop, update, and revise standard operating procedures, work instructions, material testing protocols and reports, and certificate of analyses in compliance with applicable ICH, GxP and safety regulations
  • Identify suitable material lots, determine supply needs, purchase and/or coordinate shipment of materials from external vendors or internal manufacturing
  • Ensure proper storage and inventory control of raw materials, reference standards, and critical reagents, including requalification of materials prior to the expiry date or the qualification of new lots for continuity of supply
  • Coordinate the sampling, testing and delivery of samples to internal or contract testing laboratories for qualification/requalification
  • Review all incoming vendor documentation (specifications, certificates of analysis, certificate of origin) and supporting test data from contract testing laboratories
  • Provide technical/troubleshooting support for QC lab investigations and deviations with timely resolution
  • Track and report key performance metrics routinely to upper management
  • Ensure that the QC material management program complies with all relevant regulatory requirements, as well as support audits/inspections and author relevant sections of regulatory filing documentation
  • Develop and lead material management continuous improvement efforts with internal stakeholders and material suppliers


Qualifications:
  • PhD in biological, technical, or engineering field and 4-6 years of post-doc/industry experience. Or a BS or MS degree in a relevant biological, technical, or engineering field and 12+ years for BS, or 10+ years for MS, of relevant professional experience.


Requirements:
  • Prior experience in cGMP biopharmaceutical QC laboratory and/or manufacturing
  • Strong working knowledge of current ICH, CFR, and GMP regulations and practices, especially in relation to raw materials, reference standards, and critical reagents
  • Strong working knowledge of a variety of analytical testing techniques
  • Experience in performing risk assessments, developing specifications, data review, SOP drafting, and laboratory investigations/deviations
  • Experience with working with material suppliers and contract testing laboratories, especially with establishing vendor agreements and coordinating testing
  • Excellent technical, communication, writing, and project management skills
  • Ability to lead and work independently with technical staff, both internal and external stakeholders


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