Senior Scientist, Microbiology Lead

Terrestrial Bio

Location:

Allston, MA and Woburn, MA

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

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.

• 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/fungi stasis 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.

• 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.

• 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.

Self‑starter comfortable building capabilities from the ground up.

Strong project management and ability to work to hard program deadlines.

Excel…