QC Associate Engineer, Raw Materials and Critical Reagents
Piper Companies is seeking a QC Consultant, Raw Materials and Critical Reagents in Philadelphia, PA to join a cell therapy leader committed to developing off-the-shelf cell therapies to expand patient access and provide an unparalleled opportunity to advance the course of cancer care.
Piper is looking for motivated scientists to advance the growing and promising field of cell therapy to treat cancer. The QC Consultant will be part of the Quality Control operations team that will collaborate with company 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 work closely with scientists within the group and 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 of the QC Consultant, Raw Materials and Critical Reagents:
- In collaboration with research, process and analytical development, QC laboratory, and manufacturing teams, plan and source new 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
- Identify suitable material lots, determine supply needs, purchase and/or coordinate shipment of materials from external vendors or internal manufacturing
- Work along with QC management to perform phase-appropriate risk assessments and establish material qualification mitigation strategies and specifications for GMP raw materials, reference standards, and critical reagents
- Coordinate the sampling, testing and delivery of samples to internal or contract testing laboratories for qualification/requalification
- Review and document all incoming vendor documentation (specifications, certificates of analysis, certificate of origin) and supporting test data from contract testing laboratories
- Develop, update, and revise material testing protocols and reports, specifications and certificate of analyses in compliance with applicable ICH, GxP and safety regulations
- Maintain and coordinate storage of materials internally and externally
- Ensure inventory control of materials, including monitoring and trending usage, requalification of materials prior to the expiry date or the qualification of new lots for continuity of supply
Qualifications for the QC Consultant, Raw Materials and Critical Reagents:
- B.S. degree in Biology, Chemistry, or Life Science related disipline
- 3-5 years of experience (or Masters with +1-2 years of experience) in cGMP biopharmaceutical QC laboratory and/or manufacturing
- Experience with raw materials, reference standards, and critical reagents handling, testing and/or management is preferred
- Strong working knowledge of current ICH, CFR, and GMP regulations and practices
- Experience with working with material suppliers and contract testing laboratories
- Ability to lead and work with technical staff, both internal and external stakeholders