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 the Director of CMC, 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 regulatory expertise, organization, and enthusiasm, you will leave an indelible mark on Affy.
Location: Natick, MA
SCIENTIST, PROCESS DEVELOPMENT (up to SENIOR SCIENTIST)
Process Development and Qualifications (45%)
- Support the establishment and maintenance of the PD lab, including installation & maintenance of equipment.
- Independently author method documents, protocols, and reports while following and implementing lab SOP.
- 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.
- Develop manufacturing process sufficiently robust to support later stage pipeline assets.
Lead Asset Commercialization Strategy (35%)
- Apply Quality by Design practice to ensure product and process understanding and control strategy are integrated into as-is and to-be product manufacturing processes.
- Execute studies to determine best path forward for current and future indications and products.
- Present process development studies by maintaining Good Documentation Practices.
- Author relevant sections of Briefing Books for clinical and pre-clinical development.
Operational Support (20%)
- Support tech transfer of process to GMP manufacturing facilities and in-process/final releasing assays to QC
- Internal lead for process development at CMC team meetings.
- Author relevant sections of clinical and regulatory documents.
- Perform other duties as assigned.
- Post-secondary degree and cell/gene therapy experience required. Advanced degree (PhD, PharmD, or MS) and prior oncology experience preferred.
- Experience with manufacturing scale processes using various cell culture platforms (e.g., cell factories, bags, bioreactors) and large-scale equipment.
- Experience or familiarity with in-process/drug product characterization assays for cell and gene therapy (e.g., Flow cytometry, digital droplet PCR, automated cell counting, sterility assays).
- Experience identifying and developing assays to measure critical quality attributes.
- Experienced and well-versed with FDA Guidance related to CAR T cell therapy release testing and manufacturing.
- Experience authoring and reviewing SOPs and validation documents to support regulatory filings 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
- Strong interpersonal skills and ability to thrive in a matrix environment.
- Highly adept at solving complex, cross-functional problems.
- Experience in managing external collaborations, contract laboratories, timelines, and budgets.
- Demonstration of scientific capability as evidenced by publications, patents, research reports, or presentations is a plus.
- Flexibility to work on multiple projects as the portfolio evolves over time.
- Meticulous attention to detail, including capacity to conduct thorough self-reviews.
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues.
- Highly organized, collaborative, and motivated in a fast-paced startup environment.
- Comfort with Microsoft Office (PowerPoint, Excel, Word, OneDrive, Project, Visio).
This is a salaried, benefit-eligible position.