Lead Analytical Method Scientist, Biologics & MAP

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 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