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 Process 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 the crafting and operationalization of Affy’s strategy for enhancing and commercializing its cell therapy products.
Reporting to Process Development Lead, you will join a small team at a dynamic startup. You will collaborate within and outside the company to develop and qualify assays, support technology transfer activities, and develop and execute a GMP compliant manufacturing process. With your process development expertise, organization, and enthusiasm, you will leave an indelible mark on Affy.
Location: Natick, Mass.
Scientist I, PROCESS DEVELOPMENT
Responsibilities:
Process Development (90%)
- Execute process development project plans and related characterization assays independently and in collaboration with CMC team members.
- Characterize and optimize cell culture and expansion media formulations to ensure a robust T cell engineering process.
- Plan and execute studies to determine the best path forward for current and future indications.
- Develop robust manufacturing process to support later stage pipeline assets.
- Independently author method documents, protocols, and reports.
- Assist with data compilation and trending.
- Present findings of studies to team and major stakeholders.
Operational and Lab Support (10%)
- Support maintenance of PD lab and inventory to ensure uninterrupted experiments and studies including but not limited to ordering and inventory, equipment maintenance, and waste management.
- Other duties as assigned.
Qualifications:
- B.S. Degree and 5-7 years of relevant experience, or M.S. Degree with 3-4 years of relevant experience required. Cell/gene therapy experience required.
- Experience with manufacturing scale processes using various gene and cell therapy equipment and technologies (e.g. for cell isolation, transduction, expansion, wash, harvest) preferred.
- Experience or familiarity with in-process/drug product characterization assays for cell and gene therapy (e.g. automated cell counting, flow cytometry).
- Strong sense of urgency and excellence in prioritization, planning, and execution
- Experience authoring and reviewing SOPs and batch records.
- Flexibility to work on multiple projects as the portfolio evolves over time.
- Meticulous attention to detail, including capacity to conduct thorough self-reviews.
- Highly organized, collaborative, and motivated in a fast-paced startup environment.
- Comfort with Microsoft Office (PowerPoint, Excel, Word), and GraphPad Prism (or other data analysis software).
This is a salaried, benefit-eligible position.
