Principal Scientist, Bioanalytical Assays

Company Summary: FL87, Inc. is a privately held, early-stage biotechnology company developing a novel approach to gene therapy that can address currently untreatable diseases. FL87, Inc was founded by Flagship Pioneering, an innovation enterprise that conceives, creates, resources, and grows first-in-category life sciences companies. Flagship Pioneering has created over 100 groundbreaking companies over the past twenty years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna (MRNA), Syros Pharmaceuticals (SYRS), Seres Therapeutics (NASDAQ:MCRB), Generate Biomedicines, Tessera Tx, Evelo Biosciences (EVLO), and Indigo Agriculture. Position Summary: We are seeking a highly motivated and experienced Principal Scientist with deep expertise in bioanalytical assays. This position requires expertise in with LNPs, nucleic acid therapies, biodistribution studies and bioanalytical platforms. This individual will have the opportunity to be the bioanalytical assay lead for platform and therapeutic areas, and work in a dynamic and fast-paced entrepreneurial environment as part of a highly collaborative team. Key Responsibilities: Lead the design, development, validation, and execution of bioanalytical assays to support nonclinical studies, including PK, PD, biomarker, and immunogenicity endpoints Provide scientific oversight for ligand-binding assays and cell-based assays, ensuring robust assay performance, data quality, and compliance with applicable guidelines Design and oversee biodistribution studies for LNP/nucleic acid therapies in rodents and NHPs using flow cytometry and histological techniques Partner closely with CMC, molecular biology and cell biology teams and organize and prioritize cargoes for stealth screening assays, map out timelines, and ensure timely delivery of high-quality data Design, develop and supervise various cell-based assays to assess immunogenicity to nucleic acid cargoes and establish release criteria for preclinical payloads Design and oversee various in vivo immunogenicity predictors for LNP/nucleic acid therapies including but not limited to biomarkers, cytokines, complement activation and anti-drug antibodies (ADA) and manage internal teams or CROs for timely execution and data analysis Direct, supervise, and mentor junior scientists in test procedures such as sample extraction and measurement by bDNA, ddPCR, ELISA, MSD, Luminex, RNAscope, flow cytometry and data interpretation Demonstrate flexibility to work in the lab for in vitro and in vivo experiments to help the team Present at project team meetings and to relevant stakeholders Qualifications: Ph.D. in cell biology, pharmaceutical sciences, or immunology or related field with 12+ years of experience, industry preferred Experience in design and execution of immunogenicity assays for LNP or nucleic acid cargo is highly preferred Experience developing bioanalytical methods to measure drugs and biomarkers Strong communication, presentation and interpersonal skills Proven track record of project management and mentorship skills Experience with non-viral delivery technologies and nucleic acid modalities is preferred Prior experience preparing technical reports for regulatory filings Outstanding strategic thinking, problem solving, and decision-making skills We recognize that great candidates often bring unique strengths without fulfilling every qualification . If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship. 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 ... (truncated, view full listing at source)