Senior / Principal Scientist Analytical Method Development Lead

Terrestrial Bio • Woburn, MA

1d • $125,000 - $180,000 • Onsite

About The Position

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1. Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration. Terrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules.

We are seeking an Analytical Method Development (AMD) Lead to drive the analytical method development, qualification, and validation strategy for the microneedle array patch (MAP) program. This individual will lead the development of release and characterization methods including HPLC/UPLC, LC-MS, and functional assays and own the analytical method lifecycle from Phase 2 through Phase 3 IND and commercialization. This is a senior technical leadership role for a scientist with deep peptide/biologic analytical expertise and a track record of building robust, regulatory-compliant methods.

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, or related field with 6+ years relevant experience, OR M.S. with 8+ years in pharmaceutical/biotech analytical method development.
• Deep expertise in HPLC/UPLC method development for peptides or biologics.
• Hands-on experience with LC-MS for impurity characterization and structural analysis.
• Demonstrated experience leading method validation under ICH Q2(R2)/Q14.
• Experience developing analytical control strategies and specifications for clinical-stage products.
• Strong knowledge of ICH Q6A, Q3A/B/C/D, and FDA/EMA CMC expectations.

Nice To Haves

• Experience with GLP-1 peptides or semaglutide analytical methods.
• Experience with microneedle/transdermal or drug-device combination products.
• Prior experience defining potency or cell-based functional assay strategies.
• Experience supporting IND/BLA filings and regulatory interactions.
• Experience building and scaling an analytical method development function.

Responsibilities

• Lead analytical method development for release and characterization assays including RP-HPLC/UPLC purity, content, SEC, and impurity characterization by LC-MS.
• Define and execute the analytical method validation strategy per ICH Q2(R2) and Q14.
• Develop the Validation Master Plan (VMP) governing method qualification, validation, transfer, and lifecycle management.
• Establish the impurity characterization strategy for GLP-1 peptide, including oxidation, deamidation, and related substances.
• Lead method transfers to QC and to/from external CROs.
• Define the analytical control strategy and specifications for Phase 2 Tox and Phase 3 clinical lots.
• Support characterization of reference standards and establishment of bridging strategies.
• Author analytical sections of regulatory submissions (IND, CMC) and serve as analytical SME during inspections.
• Guide the development of the potency/functional assay strategy in collaboration with pre-clinical and formulation teams.
• Mentor and develop method development scientists; provide technical leadership across the AMD function.

Benefits

• The anticipated base salary range for this position is $125,000 - $180,000. Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree