Senior Scientist, Microbiology Lead

About the role

We are seeking an experienced Microbiology Lead to establish and lead our in-house GMP Microbiology laboratory supporting the microneedle array patch (MAP) program from Phase 2 through commercialization.

Responsibilities

• Establish and lead the in-house GMP Microbiology laboratory, including equipment specification, procurement, installation, and IQ/OQ/PQ qualification.
• Develop, qualify, and validate microbiological test methods including Bioburden (USP /), Bacterial Endotoxin/BET (USP), and Environmental Monitoring per USP.
• Design and implement the Environmental Monitoring program including sampling location maps, alert and action limits, trending, and periodic reporting to Quality.
• Execute method suitability and validation studies on the VX-201 product matrix, including bacteriostasis/fungistasis and inhibition/enhancement testing.
• Lead the 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 OOS/OOT investigations, root cause analysis, and 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 inspections.

Requirements

• Ph.D. in Microbiology, Biology, or related field with 6+ years relevant experience, OR M.S. with 10+ years in a pharmaceutical/biotech GMP microbiology environment.
• Demonstrated experience establishing or operating a GMP microbiology laboratory.
• Hands-on expertise in Bioburden, BET/Endotoxin, and Environmental Monitoring methods and their validation.
• Working knowledge of USP, , , , and applicable 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

• Experience supporting drug-device combination products or novel delivery platforms.
• Experience with rapid microbiological methods (e.g. Milliflex Rapid) and endotoxin systems (e.g. Endosafe).
• Prior experience supporting regulatory inspections (FDA, EMA).
• Experience building and leading teams in a clinical-stage biotech.

Skills

• Self-starter comfortable building capabilities from the ground up.
• Strong project management and ability to work to hard program deadlines.
• Excellent written and verbal communication and cross-functional collaboration.
• Meticulous attention to detail and documentation rigor.

Benefits

The anticipated base salary range for this position is $130,000 - $160,000. Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.

Pay

The anticipated base salary range for this position is $130,000 - $160,000.

Schedule

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.