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Salary: USD 125,000 - 180,000 / annual
Terrestrial Bio is seeking a Senior Scientist to lead analytical method development for its Tacterra™ microarray patch (MAP) platform, a proprietary transdermal delivery system designed to administer GLP-1 and other therapeutics via self-administered patches that dissolve bioactive tips into the skin without needles or refrigeration.
In this role, you will own the analytical method lifecycle from Phase 2 through Phase 3 IND and commercialization. Key responsibilities include:
• Lead development of release and characterization methods (RP-HPLC/UPLC, LC-MS, SEC, functional assays) for the microneedle array patch program
• Define and execute analytical method validation strategy per ICH Q2(R2) and Q14 guidelines
• Develop the Validation Master Plan governing method qualification, validation, transfer, and lifecycle management
• Establish impurity characterization strategy for GLP-1 peptide, including oxidation, deamidation, and related substances
• Lead method transfers to QC and external CROs
• Define analytical control strategy and specifications for Phase 2 Tox and Phase 3 clinical lots
• Support characterization of reference standards and bridging strategies
• Author analytical sections of regulatory submissions (IND, CMC) and serve as analytical subject matter expert during inspections
• Guide potency and functional assay strategy development in collaboration with pre-clinical and formulation teams
• Mentor and develop method development scientists; provide technical leadership across the analytical method development function
You bring a Ph.D. in Analytical Chemistry, Biochemistry, or related field with 6+ years of relevant experience (or M.S. with 8+ years in pharmaceutical/biotech analytical method development). Deep expertise required in HPLC/UPLC method development for peptides or biologics, hands-on LC-MS experience for impurity characterization, and demonstrated experience leading method validation under ICH Q2(R2)/Q14. Strong knowledge of ICH Q6A, Q3A/B/C/D, and FDA/EMA CMC expectations is essential.
Preferred qualifications include experience with GLP-1 peptides or semaglutide analytical methods, microneedle/transdermal or drug-device combination products, potency or cell-based functional assay strategies, IND/BLA filings, and building/scaling analytical method development functions.
You combine deep technical expertise with strategic program thinking, strong leadership and mentoring capability, excellent scientific writing and regulatory communication skills, and the ability to balance scientific rigor with program timelines in a fast-paced environment. The role is based in Woburn, MA with a new facility in Allston, MA opening Q4 2026, requiring onsite presence 4-5 days per week.
