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Salary: USD 130,000 - 160,000 / annual
Terrestrial Bio is seeking an experienced Microbiology Lead to establish and lead an in-house GMP Microbiology laboratory supporting the company's microneedle array patch (MAP) program from Phase 2 through commercialization. This is a hands-on leadership role in a fast-paced, build-phase biotech environment focused on transforming drug delivery, starting with GLP-1 therapeutics.
Key responsibilities include:
- Establish and lead the GMP microbiology lab from the ground up, including equipment specification, procurement, installation, and IQ/OQ/PQ qualification
- Develop, qualify, and validate microbiological test methods including Bioburden (USP <61>/<62>), Bacterial Endotoxin/BET (USP <85>), and Environmental Monitoring (USP <1117>)
- Design and implement a comprehensive Environmental Monitoring program with sampling location maps, alert/action limits, trending, and reporting
- Execute method suitability and validation studies on the VX-201 product matrix, including bacteriostasis/fungistasis and inhibition/enhancement testing
- Lead transfer of microbiological methods from external CROs to in-house operations
- Author and maintain microbiology SOPs, protocols, and qualification documentation in compliance with GMP requirements
- Manage microbiological out-of-specification (OOS) and out-of-trend (OOT) investigations, root cause analysis, and corrective/preventive actions (CAPA)
- Support facility contamination control strategy, cleanroom monitoring, and material/personnel flow design
- Hire, train, and mentor microbiology staff as the function scales toward Phase 3
- Serve as microbiology subject matter expert for regulatory submissions (IND, CMC) and FDA/EMA inspections
Required qualifications:
- Ph.D. in Microbiology, Biology, or related field with 6+ years relevant experience, OR M.S. with 10+ years in pharmaceutical/biotech GMP microbiology
- Demonstrated experience establishing or operating a GMP microbiology laboratory
- Hands-on expertise in Bioburden, BET/Endotoxin, and Environmental Monitoring methods and validation
- Working knowledge of USP <61>, <62>, <85>, <1111>, and FDA/ICH regulatory requirements
- Experience with equipment qualification (IQ/OQ/PQ) and method validation
- Strong understanding of contamination control, aseptic technique, and GMP data integrity
Preferred qualifications include experience with drug-device combination products, novel delivery platforms, rapid microbiological methods, regulatory inspections, and building/leading teams in clinical-stage biotech.
The role requires strong project management, cross-functional collaboration, meticulous attention to detail, and the ability to thrive in a fast-paced, build-phase environment. Onsite expectations are 4-5 days per week at facilities in Woburn, MA and the new custom facility in Allston, MA (planned for Q4 2026).
