Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1. Terrestrial. Backed by Ulu Ventures.
About the role
Lead analytical method development for release and characterization assays including RP-HPLC/UPLC purity, content, SEC, and impurity characterization by LC-MS. Define and execute the analytical method validation strategy per ICH Q2(R2) and Q14. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Ph.D. in Analytical Chemistry, Biochemistry, or related field with 6+ years relevant experience, OR M.S. with 8+ years in pharmaceutical/biotech analytical method development
- Deep expertise in HPLC/UPLC method development for peptides or biologics
- Hands-on experience with LC-MS for impurity characterization and structural analysis
- Demonstrated experience leading method validation under ICH Q2(R2)/Q14
- Experience developing analytical control strategies and specifications for clinical-stage products
- Strong knowledge of ICH Q6A, Q3A/B/C/D, and FDA/EMA CMC expectations
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 Analytical Method Development (AMD) Lead to drive the analytical method development, qualification, and validation strategy for the microneedle array patch (MAP) program. This individual will lead the development of release and characterization methods including HPLC/UPLC, LC-MS, and functional assays and own the analytical method lifecycle from Phase 2 through Phase 3 IND and...
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