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 Analytical Development Scientist 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, optimizing, and validating analytical tools and strategies for our CAR T products and manufacturing.

Reporting to the Director of CMC, 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, vendor management, and cell therapy expertise, you will leave an indelible mark on Affy.

Location: Natick, MA

SCIENTIST, ANALYTICAL DEVELOPMENT (RESEARCH ASSOCIATE/SENIOR SCIENTIST DOE)

Responsibilities:

Analytical Development Strategy and Execution (60%)

• Develop, qualify, and validate 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.
• Perform 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.
• Build, quality control, and maintain lentiviral vector release plan for pipeline assets.

Operational Support and Vendor Management (40%)

• Identify and assess vendors for outsourcing of developed assays and quality control release tests.
• Manage technology transfer to, and results reporting from, commercial manufacturing organization and/or assay vendors.
• 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:

• Advanced degree (PhD, PharmD, or MS) and human T cell biology experience required. Knowledge of basic immunology and cell biology techniques, including mammalian cell culture, is required.
• Prior experience with the design, execution, optimization, and validation of a broad range of in vitro cell based assays is required. Prior oncology, cell therapy, and/or CAR T experience preferred.
• Experience with analytical method development and validation for a variety of cell-based bioassays, including potency, mycoplasma, replication competent lentivirus, vector copy number, and sterility.
• Experienced and well-versed with FDA Guidance related to CAR T cell therapy manufacturing and release testing and industry whitepapers for state-of-the-art method validation of manufacturing assays. This individual will apply FDA recommendations and industry best practices to validation and deployment of assessing critical quality attributes.
• Understanding of the regulatory and commercialization requirements for product release testing.
• CMC assay development/QC experience in clinical and cGMP environment is a plus.
• Outstanding written and oral communication skills for clinical, business, and scientific audiences.
• Strong sense of urgency and excellence in prioritization, planning, and execution