FL68: Senior Scientist, Analytical Development

Company Summary:

Flagship Labs 68 (FL68) is a privately held, well-funded, early-stage biotechnology company that is developing a novel cell therapy platform, which leverages unique cell types and behaviors to perform entirely new therapeutic functions. Fully realized, the FL68 platform technology will tackle a massive spectrum of diseases, drastically extending the reach of cell therapy for human health. We are a dynamic, entrepreneurial, and innovation-driven group seeking collaborative and dedicated people to join our team.

Position Summary:

FL68 is seeking a Senior Scientist of Analytical Development to oversee activities related to the assay development for an iPSC-derived cell therapy. This role requires scientific expertise, leadership, and cross-functional collaboration to accelerate the IND-enabling stage and early clinical stages of our products. The candidate must have excellent communication skills and be willing to work in a highly dynamic and fast-paced, entrepreneurial environment. This role will report to the Director of Product Development.

Key Skills:

• Lead analytical development efforts to implement relevant quality control assays for IND-enabling studies
• Develop, optimize, and qualify analytical methods that meet precision and accuracy standards for iPSC-derived cell products
• Ensure consistent method development and data generation
• Write SOPs and written reports in compliance with regulatory standards.
• Collaborate cross-functionally to introduce new assays that enhance process and product understanding
• Effectively communicate scientific findings in project team meetings
• Perform routine lab activities, as needed.

Preferred Qualifications:

• • PhD in Immunology, Biological Sciences, Biomedical Engineering, or related field with 5+ years of relevant experience; a MS with 10+ years of relevant experience; a BS with 12+ years of industry experience.
  • Knowledge of analytical processes within regulated environments and phase appropriate regulatory expectations for cell and gene therapies.
  • Proficient in standard cell-based and protein assays including ELISA, flow cytometry, and viability
  • Experience with potency assay development, external assay tech transfer, and iPSC cell culture is highly desired.
  • Experience in a start-up environment is a plus.

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.