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 an Senior or Principal Research Associate in Analytical Development to help advance the use of CAR T therapy for solid tumors. As part of the CMC team, you will play a primary role in developing and assessing analytical tools and strategies for our CAR T products and manufacturing.
Reporting to the Analytical Development Lead, you will join a small team at a dynamic startup. You will collaborate within and outside the company to develop, optimize and validate analytical tools and strategies for release and manufacturing of our CAR T products. With your analytical development expertise within cell therapy, you will leave an indelible mark on Affy.
Location: Natick, MA
SENIOR (PRINCIPAL) RESEARCH ASSOCIATE, ANALYTICAL DEVELOPMENT
Responsibilities:
Analytical Development Execution (70%)
- Develop and assess assays for product release testing.
- Lead CAR T release assay development, qualification, validation, and transfer activities.
- Perform and coordinate testing to support clinical and commercial manufacturing process, process development and validation, and research and development efforts.
- Write protocols and reports establishing methods of analytical testing and reporting results thereof.
- Contribute to novel assay development or validation of established drug product releasing tests in collaboration with manufacturing and process development teams.
- Design, execute, summarize, and present analytical development studies.
- Maintain laboratory notebooks and prepare written protocols (SOPs) and reports in a GMP/GDP compliant manner consistent with ALCOA principles.
Operational Support and Vendor Management (30%)
- Partner with vendors for outsourcing of developed assays and quality control release tests.
- Assist in technology transfer to, and results reporting from, CDMOs and CTLs.
- Assist in development of clinical manufacturing documents (IND amendments, master batch records, etc.)
- Support drug IND and BLA filings in conjunction with quality assurance and regulatory.
- Perform other duties as assigned.
Qualifications:
- 3+ (5+ for Principal) years of experience with basic immunology and cell biology techniques, including mammalian cell culture, required. Advanced degree (PhD, PharmD, or MS) considered year-for-year in lieu of work experience. Understanding of immunology, T-cell biology, and CAR T cell manufacturing is required.
- Prior experience with the execution, optimization, and validation of a broad range of in vitro cell based assays, including (but not limited to) cytotoxicity assays, ddPCR, flow cytometry, and RTCA is required.
- Understanding of the regulatory and commercialization requirements for product release testing.
- Experience with graphing and statistical analysis software such as GraphPad Prism or equivalent is required.
- Outstanding written and oral communication skills for clinical, business, and scientific audiences.
- Strong sense of urgency and excellence in prioritization, planning, and execution.
- Strong interpersonal skills and ability to thrive in a matrix environment; adept at solving complex, cross-functional problems. Highly organized, collaborative, and motivated in a fast-paced startup environment.
- Effective verbal and written communication skills within and outside the company
- Meticulous attention to detail, including capacity to conduct thorough self-reviews.
- Comfort with Microsoft Office (PowerPoint, Excel, Word, OneDrive, Project, Visio).
This is a salaried, benefit-eligible position.
