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)

Responsibilities:

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.

Qualifications:

  • 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.

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