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Senior Scientist, Microbiology Lead

Vaxess Technologies · Woburn, MA · On-site

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About Vaxess Technologies

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

About the role

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 . Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • 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
More about this role

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 .

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...

Read the full posting on Vaxess Technologies's site ↗

Analytical Sciences

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