AffyImmune Therapeutics (“Affy”), a clinical stage biotechnology company focused on developing technologies that expand the utility and improve the safety and efficacy of cell-based immunotherapy for cancer, is seeking a Quality Assurance (QA) Associate (Senior Associate, or Manager, DOE) to help advance the use of CAR T therapy for solid tumors. As part of the clinical team, you will ensure phase-appropriate Good Manufacturing Practices are followed, maintain internal quality documentation, and act as the quality liaison with contract manufacturers and laboratories.
Reporting to the Head of CMC, you will join a small team at a dynamic startup. You will collaborate within and outside the company to help us advance our clinical development. With your regulatory expertise, organization, and attention to detail, you will leave an indelible mark on Affy.
Location: Natick, MA, or Remote
QUALITY ASSURANCE (QA) ASSOCIATE (SENIOR ASSOCIATE, OR MANAGER, DOE)
Documentation System (65%)
- Maintain quality management document system, including SOPs, protocols, reports, and related files.
- Write, review, and approve SOPs, 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 and contractor qualification records.
- With the Quality Control Associate, maintain QC laboratory in state of compliance, including procedures, equipment maintenance and calibration, lab notebook management, and lab records management
External Quality Liaison (35%)
- Assist in qualifying contract manufacturers and laboratories
- Ensure Affy and partner organizations we contract with uphold their responsibilities under quality agreements
- Liaise with contract manufacturers and laboratories for day-to-day quality-related issues; for example, facilitate reviews of documents, manage manufacturing issues, manage change requests, and review and manage deviations
- For Associate, B.S. in life sciences (biology, chemistry, biochemistry, immunology, etc.) 3+ years of relevant experience in a GMP environment in biologics manufacturing or in a QA 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, benefits-eligible position.