Principal Scientist, Bioanalytical Assays

Flagship Pioneering, Inc.•Cambridge, MA

9d•$163,000 - $214,500

About The Position

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.

Requirements

Ph.D. in cell biology, pharmaceutical sciences, or immunology or related field with 12+ years of experience, industry 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
Outstanding strategic thinking, problem solving, and decision-making skills

Nice To Haves

Experience in design and execution of immunogenicity assays for LNP or nucleic acid cargo is highly preferred
Experience with non-viral delivery technologies and nucleic acid modalities is preferred
Prior experience preparing technical reports for regulatory filings

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