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, the Process Development Scientist 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.
