GMP Microbiology Lead for MAP Platform

Terrestrial

Woburn (MA)

Hybrid

USD 130,000 - 160,000

Full time

14 days+

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Job summary

Terrestrial Bio, Inc. is building an in-house GMP Microbiology lab to support the MAP program from Phase 2 to commercialization. The role requires hands-on leadership to establish Bioburden, BET, and Environmental Monitoring capabilities, ensuring qualification for manufacturing and clinical supply.

You will hire and mentor staff and interact with regulatory teams. The position offers a fast-paced biotech environment with a focus on regulatory readiness and quality-driven microbiology

Qualifications

Ph.D. in Microbiology or related field with 6+ years GMP microbiology experience.
Hands-on GMP microbiology lab experience with Bioburden, BET/Endotoxin, and Environmental Monitoring.
Experience with IQ/OQ/PQ and method validation.
Strong GMP data integrity and documentation discipline.

Responsibilities

Establish and lead in-house GMP Microbiology laboratory with IQ/OQ/PQ qualification.
Develop, qualify, and validate microbiological test methods (Bioburden, BET/Endotoxin, EM).
Design Environmental Monitoring program, sampling maps, limits, trending and reporting.
Transfer microbiological methods from CROs to in-house operations.
Author and maintain microbiology SOPs and qualification documents.
Lead OOS/OOT investigations and CAPA; support contamination control.
Mentor microbiology staff; prepare for Phase 3 scale-up.
Support regulatory submissions (IND, CMC) and regulatory inspections.

Job description

You will hire and mentor staff and interact with regulatory teams. The position offers a fast-paced biotech environment with a focus on regulatory readiness and quality-driven microbiology

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