Lead Analytical Method Development for Biologics

Terrestrial Bio, Inc.; Woburn (MA); Hybrid; USD 125,000 - 180,000; Full time

Job summary

Terrestrial Bio, Inc. in Allston and Woburn, MA seeks an Analytical Method Development Lead to drive release and characterization method development, validation, and lifecycle management for the MAP program, including RP-HPLC/UPLC, LC-MS, and impurity profiling.

You will author regulatory sections, oversee transfers to QC and CROs, mentor scientists, and shape the analytical strategy for Phase 2/3 IND and commercialization.

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, or related field with 6+ years relevant experience, OR MS with 8+ years.
• Deep expertise in HPLC/UPLC method development for peptides or biologics.
• Hands-on 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.

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.

Skills

HPLC/UPLC method development

LC-MS impurity characterization

Method validation (ICH Q2(R2)/Q14)

Analytical control strategies

CMC regulatory writing

ICH Q6A/Q3A/B/C/D knowledge

Education

PhD in Analytical Chemistry/Biochemistry

MS in a related field

Tools

LC-MS instrumentation

HPLC/UPLC systems

Job description

Terrestrial Bio, Inc. in Allston and Woburn, MA seeks an Analytical Method Development Lead to drive release and characterization method development, validation, and lifecycle management for the MAP program, including RP-HPLC/UPLC, LC-MS, and impurity profiling.

You will author regulatory sections, oversee transfers to QC and CROs, mentor scientists, and shape the analytical strategy for Phase 2/3 IND and commercialization.