The Opportunity:- 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 multiple projects.
- Demonstrate technical expertise on analytical technologies and act as a subject matter expert for Analytical Development function.
- Select appropriate analytical techniques and coach and/or manage the contract lab counter parts to perform analytical method development/validation/transfer to support 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:- Master's degree with 10+ years or PhD with 8+ years of relevant industrial experience in analytical development.
- Extensive experience leading analytical activities independently in small molecule drug development.
- Experience managing projects at CROs/CDMOs.
- Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).
- Effective written and verbal communication skills and interpersonal skills.
- Extensive knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.
- Strong problem-solving skills with sound technically driven decision-making ability.
- 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 resolution of problems.
- Ability to multi-task and thrive in a fast-paced innovative environment.
Preferred Skills: - PhD (minimum MS degree) in analytical chemistry, organic chemistry or related discipline.
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The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Base Pay Salary Range
$170,000-$212,000 USD
