AffyImmune Therapeutics, 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 professional to help advance the use of CAR T therapy for solid tumors. As part of the Quality team, you will play a key role in oversight of contract manufacturing, testing, and drug product disposition.
Reporting to the Vice President of Quality, the QA (Sr.) Manager will collaborate with internal and contract manufacturing organizations on technology transfer and manufacturing oversight. In addition, you will be involved in further development of Affy’s QMS for late-stage clinical trials. Key internal interfaces include Process Development, Analytical Development, Manufacturing, Supply Chain, and Clinical Operations.
Location: Natick, MA, or Remote
QUALITY ASSURANCE (QA) MANAGER (SENIOR MANAGER, DOE)
Quality Assurance Operations (75%)
- Oversee GMP production at contract manufacturing facilities.
- Review and approve vendor production batch records and protocols.
- Participate in deviation investigations, development, and implementation of Corrective and Preventive Actions.
- Liaise with contract manufacturers and laboratories for day-to-day quality related issues.
- Partner with internal CMC team on process and analytical technology transfers, qualification, and validation.
- Partner with internal and vendor teams in development and approval of Master Batch Records and associated controlled documents.
- Partner with Supply Chain and the Clinical Operations in managing starting materials and drug product transfers and patient dosing.
Quality Management System Build (25%)
- Assess gaps and author Standard Operating Procedures, Work Instructions, and forms in preparation for increased clinical activity and commercialization.
- Manage technology transfer to, and results reporting from, commercial manufacturing organization and/or assay vendors.
- Other duties as assigned.
Qualifications:
- BS/MS in Biological Sciences, Chemical Engineering, or related fields. Minimum of 8 years of Quality Assurance experience in biopharmaceutics with a minimum of 3 years in human cell therapy platforms.
- Experience with overseeing Contract Manufacturing organizations.
- Experience with process and analytical methods technology transfer and validation.
- Working knowledge of aseptic operations, environmental monitoring, and GMP Manufacturing highly desired.
- 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) and electronic document management systems (Veeva, e.g.).
This is a salaried, benefits-eligible position.
