RedwoodCityRecruiter Since 2001
the smart solution for Redwood City jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Redwood City RSS job feeds