Sr. Scientist, Analytical Development- CMC

Company: Planet Pharma
Location: Redwood City
Posted on: November 19, 2022

Job Description:

527821
Our client, a leading Pharmaceutical company in Redwood City, CA, is looking for a Senior Scientist- Analytical Development.
Required Skills:

• Ph.D. or M.S. in analytical chemistry, organic chemistry, or a related discipline.
• 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.
  Responsibilities:
  • 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 projects.
  • Demonstrate technical expertise in analytical technologies and act as a subject matter expert for the Analytical Development function.
  • 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 CTLs).
  • 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 experience

Keywords: Planet Pharma, Redwood City , Sr. Scientist, Analytical Development- CMC, Other , Redwood City, California