Sr. Scientist, Analytical Development- CMC
Company: Planet Pharma
Location: Redwood City
Posted on: November 19, 2022
Our client, a leading Pharmaceutical company in Redwood City, CA,
is looking for a Senior Scientist- Analytical Development.
- Ph.D. or M.S. in analytical chemistry, organic chemistry, or a
- 3+ years of relevant experience in analytical development
preferably supporting early-phase drug development.
- Hands-on experience in analytical method development using
HPLC/UPLC/GC, cKF, and dissolution.
- Working experience and knowledge of regulatory submission (IND,
IMPD, and/or NDA).
- Knowledge and understanding of current ICH guidelines, GMP
guidelines, and related industry practices.
- Lead day-to-day operations to provide analytical support for
API process R&D and manufacturing, formulation development, and
drug product manufacturing, and participate in cross-functional
project team meetings.
- Contribute to analytical development strategy for a variety of
- Demonstrate technical expertise in analytical technologies and
act as a subject matter expert for the Analytical Development
- Select appropriate analytical techniques and coach and/or
manage the contract lab counterparts to perform analytical method
development/validation/transfer to support the development and
manufacturing of API and drug product.
- Critically review data from contract partners (CDMOs and/or
- Manage stability testing programs assigned.
- Prepare, review, and/or approve study protocols, study reports,
and CMC regulatory submission document.
- Collaborate with cross-functional teams including but not
limited to Medicinal Chemistry, DMPK, Toxicology, QA,
Pharmaceutical Development, Process R&D, Project Management,
and Regulatory to timely achieve project goals.
Compensation within this range will be commensurate with level of
Keywords: Planet Pharma, Redwood City , Sr. Scientist, Analytical Development- CMC, Other , Redwood City, California
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