Principal Scientist/Senior Principal Scientist, Bioanalytical Lead

Responsibilities

• Lead bioanalytical strategy and execution for non-GLP and GLP PK, TK, and clinical studies across small molecule, peptide, and biologic programs
• Develop, qualify, and validate LC-MS/MS methods for small molecules and peptides in biological matrices
• Develop and validate LBA/hybrid LC-MS methods for biologics including PK and ADA assays
• Serve as the Clinical Bioanalytical Lead for assigned programs, including oversight of method transfer to clinical CROs
• Manage all outsourced bioanalytical activities, serving as the primary scientific and operational interface with CRO partners
• Oversee CRO study execution, data quality, timelines, and deliverables to ensure alignment with regulatory standards
• Coordinate DMPK operational activities including study scheduling, sample management, and logistics across multiple programs
• Collaborate with cross-functional teams (DMPK, Clinical Pharmacology, Toxicology, and CMC) to ensure integrated support

Requirements

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
• 8+ years of industry experience (for Principal Scientist) or 10+ years (for Senior Principal Scientist)
• Deep expertise in LC-MS/MS bioanalysis for small molecules and peptides
• Strong working knowledge of LBA platforms (MSD, ELISA) and hybrid LC-MS methods for biologics
• Experience with GLP bioanalytical method validation per FDA/EMA guidance
• Proven experience managing outsourced bioanalytical programs and CRO relationships
• Demonstrated ability to manage complex operational activities across multiple programs simultaneously

Preferred Qualifications

• Experience with both non-GLP and GLP studies from discovery through IND-enabling and clinical stages
• Experience working in a biotech or drug discovery environment supporting multiple internal and partnered programs
• Experience serving as operations lead for ADME and/or PK studies
• Familiarity with immunogenicity assay strategy and ADA method development
• Experience with AI/ML tools to drive efficiency and innovation in bioanalysis and DMPK operations

About the Company

Pioneering Medicines, Flagship Pioneering’s in-house drug development unit, is dedicated to conceiving and developing a broad portfolio of life-changing treatments built from Flagship’s innovative platforms. We work to accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery, development, and production.