Senior Scientist, Microbiology Lead

Terrestrial Bio, Inc.; Woburn (MA); Hybrid; USD 130,000 - 160,000; Full time

Job summary

Terrestrial Bio, Inc. in Allston, MA and Woburn, MA seeks an experienced Microbiology Lead to build and lead the in-house GMP Microbiology laboratory supporting the MAP program through Phase 3.

You will establish Bioburden, BET, and Environmental Monitoring capabilities, ensure lab qualification, method validation, and regulatory readiness; lead a fast-paced build phase and mentor staff.

The role requires onsite commitment 4-5 days/week with compensation range $130,000-$160,000.

Qualifications

• Ph.D. in Microbiology or related field with 6+ years GMP microbiology in pharma/biotech; or M.S. with 10+ years.
• GMP microbiology laboratory establishment/operation experience.
• Hands-on Bioburden, BET/Endotoxin, Environmental Monitoring and validation experience.
• Working knowledge of USP <61>, <62>, <85>, <1111> and FDA/ICH regulatory requirements.
• Experience with IQ/OQ/PQ qualification and method validation.
• Strong understanding of contamination control, aseptic technique, and GMP data integrity.

Responsibilities

• Establish and lead in-house GMP Microbiology lab with IQ/OQ/PQ qualification.
• Develop, qualify, and validate microbiological methods (Bioburden, BET, EM).
• Design Environmental Monitoring program with sampling maps and limits.
• Execute method suitability and validation on VX-201 product matrix (inhibition tests).
• Transfer microbiological methods from CROs to in-house operations.
• Author and maintain microbiology SOPs and qualification docs per GMP.
• Manage OOS/OOT investigations and CAPA.
• Support contamination control, cleanroom monitoring, and flow design.
• Hire, train, mentor microbiology staff as function scales.
• Serve as microbiology SME for IND/CMC submissions and inspections.

Skills

GMP Microbiology Leadership

Bioburden & Endotoxin

Environmental Monitoring

Regulatory GMP knowledge

Equipment Qualification (IQ/OQ/PQ)

Method Validation

Contamination Control

Team Leadership

Education

Ph.D. in Microbiology

M.S. in Microbiology

Tools

Milliflex Rapid

Endosafe endotoxin system

Job description

Terrestrial Bio

Location: Allston, MA and Woburn, MA

About Terrestrial Bio, Inc.

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1.

Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration.

Terrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules. For more

information, visit www.terrestrialbio.com.

Why this 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. This individual will build the microbiology function from the ground up including Bioburden, Bacterial Endotoxin (BET), and Environmental Monitoring (EM) capabilities and ensure the lab is fully operational and qualified to support Tox manufacturing and Phase 3 clinical supply.

This is a hands‑on leadership role for a scientist who thrives in a fast‑paced, build‑phase biotech environment.

What you'll do

• 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 <61>/<62>), Bacterial Endotoxin/BET (USP<85>), and Environmental Monitoring per USP <1117>.




• 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.

Who you are

• 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 <61>, <62>, <85>, <1111>, 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.

Key Competencies

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.

Compensation:

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.

Onsite expectations:

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.

Location:

Woburn, MA and our new, custom facility in Allston MA planned for Q4 of 2026.

At Terrestrial, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. We aim to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.