Senior / Principal Scientist Analytical Method Development Lead

Terrestrial Bio; Woburn (MA); On-site; USD 125,000 - 180,000; Full time

Benefits offered by this job

Onsite 4-5 days/week

Hybrid work options

Job summary

Terrestrial Bio in Allston MA and Woburn MA is seeking an Analytical Method Development (AMD) Lead to drive the analytical strategy for the MAP program. This senior role leads development of release and characterization methods including HPLC/UPLC, LC-MS, and functional assays, owning lifecycle from Phase 2 through IND and commercialization.

Ideal candidate has a PhD in Analytical Chemistry with 6+ years in pharma/biotech, deep peptide/biologic method expertise, and strong regulatory writing

Qualifications

• Ph.D. in Analytical Chemistry or related field with 6+ years of Biotech/pharma experience.
• Deep expertise in HPLC/UPLC method development for peptides or biologics.
• 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 for clinical-stage products.
• Strong knowledge of ICH Q6A, Q3A/B/C/D, and FDA/EMA CMC expectations.

Responsibilities

• Lead method development for RP‑HPLC/UPLC purity, content, and impurities.
• Define and implement validation per ICH Q2(R2) and Q14.
• Develop the Validation Master Plan (VMP) and lifecycle management.
• Establish impurity characterization strategy for GLP-1 peptide.
• Lead method transfers to QC and CROs.
• Define control strategy and specs for Phase 2/3 clinical lots.
• Support reference standards characterization and bridging strategies.
• Author analytical sections of IND/CMC submissions and assist inspections.
• Mentor method development scientists and provide technical leadership.

Skills

HPLC/UPLC

LC-MS impurity

Method validation

Regulatory writing

Leadership

Education

Ph.D. in Analytical Chemistry

MS in related field

Job description

Terrestrial Bio

Location: Allston, MA and Woburn, MA

About Terrestrial Bio, Inc.

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. For more information, visit www.terrestrialbio.com.

Why this role

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.

What you’ll do

• 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.

Who you are

• 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.

Preferred Qualifications

• 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.

Key Competencies

• Deep technical expertise combined with strategic program thinking.

• Strong leadership and mentoring capability.

• Excellent scientific writing and regulatory communication.

• Ability to balance scientific rigor with program timelines in a fast‑paced environment.

Compensation:

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.

Onsite expectations:

The majority of our roles at Terrestrial are either onsite or hybrid, which allows us to meet both business and team needs. Candidates applying must be willing to be onsite 4-5 days per week.

Location:

Woburn, MA and our new, custom facility in Allston MA planned for Q4 of 2026.

At Terrestrial, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. We aim to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.