Skip to content

Job Openings

Senior Scientist, Analytical Development - CMC

Redwood City, CA 94063

Posted: 03/22/2023 Employment Type: Contract Job Category: Scientific Job Number: 547399 Is job remote?: Yes Country: United States

Job Description

The Opportunity:
pay rate range: $70-80/hr

  • 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.

Required Experience, Skills, and Education:

  • 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.

  • Excellent scientific and business communication skills (verbal, written, and technical), strong interpersonal/collaboration skills, and planning skills.

  • Ability to think critically and creatively and be able to work independently to determine appropriate resources for the resolution of problems.

  • Ability to multi-task and thrive in a fast-paced innovative environment.
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

Wordpress Social Share Plugin powered by Ultimatelysocial