Senior Quality Control Specialist

Company: GQR Global Markets
Location: Cambridge
Posted on: August 3, 2022

Job Description:

Company: Well-funded, early stage cell therapy companyLocation: Cambridge, MA - Lab based role Title: Flexible, up to Senior Scientist
The Quality Control Specialist will collaborate with the R&D groups to develop Quality Control test methods required to support the derivation of gene edited iPSC lines as well as manufacturing and release testing of iPSC-derived T, B and NK cell therapeutics for immune-oncology indications.
You will oversee development and execution of cGMP-compliant test methods for both internal and out-sourced testing programs. This position will be responsible for authoring, reviewing and approving QC SOPs and related documentation to support GMP manufacturing and QC testing in compliance with applicable US and global requirements. This hire will also be responsible for qualifying and validating analytical methods as well as overseeing tech transfer of analytical methods to external collaborators and CDMOs.
Basic Qualifications:

• BSc in Biology or related field and 5+ years of relevant experience relevant in QC assay development, qualification and validation.
• Hands-on experience in flow cytometry, PCR, and/or genetic analysis required with experience in analyzing gene edited cells (CRIPR/Cas9) highly desirable.
• Experience in iPSC culture is highly desirable.
• Experience with GDP and working experience in a GLP or cGMP regulated field is essential.
• Experience in statistical analysis of data.

Keywords: GQR Global Markets, Cambridge , Senior Quality Control Specialist, Other , Cambridge, Massachusetts