AffyImmune Therapeutics (“Affy”), a clinical stage biotechnology company focused on creating technologies that expand the utility and improve the safety of cell-based immunotherapy for cancer, is seeking an Associate, Quality Control and Assurance to ensure phase-appropriate GMP requirements are met by Affy, its contract manufacturers, and its contract laboratories; maintain internal quality-related documentation; and maintain phase-appropriate GMP compliance in Affy’s QC laboratory.
As our first Quality hire, you will join a small team at a dynamic startup. You will collaborate within and outside the organization to help us meet our clinical compliance needs. With your superb communication skills, attention to detail, and flexibility, you will leave an indelible mark on Affy.
Location: Natick, MA
Current GMP Documentation Maintenance
- Maintain quality management document system, including SOPs, protocols, reports, and related files.
- Write, review, and approve SOP, protocols, forms, and templates.
- Review and approve executed manufacturing batch records and related records prior to batch release; escalate issues as they arise.
- Maintain batch documentation files.
- Maintain contractor qualification records.
- Maintain QC Laboratory in state of compliance, including procedures, equipment maintenance and calibration, Lab notebook management, laboratory records management.
- May conduct cell manufacturing and related assays such as ddPCR to characterize CAR T cells and mycoplasma.
- Perform other duties as assigned.
Contract Organization Interaction
- Ensure Affy and organizations we contract with uphold their responsibilities under quality agreements
- Assist in qualifying contract manufacturers and contract laboratories.
- Act as main liaison to contract manufacturer and laboratories for day-to-day quality-related issues including document reviews, issue management, change request management, and deviation reviews.
- Bachelor of Science with a major in life sciences (biology, chemistry, biochemistry, immunology, etc.)
- 3+ years of relevant experience in a GMP environment in biologics manufacturing or in a Quality role.
- Working knowledge of aseptic manufacturing, cGMP, and cell/gene therapy products.
- Excellent written and verbal communication and data analysis skills.
- Meticulous attention to detail, including capacity to conduct thorough self-reviews.
- Ability to interpret, summarize, and present problems and discern criticality of issues for escalation.
- Strong work ethic, enthusiasm, eagerness to learn, and willingness to perform ad-hoc tasks.
- Highly organized, collaborative, and motivated in a fast-paced startup environment.
- Comfort with Microsoft Office (PowerPoint, Excel, Word, OneDrive).
This is a salaried, benefit-eligible position.