The Opportunity:- Provide support for stability program management, quality systems and QC documentation (e.g. SOPs) and PAI readiness and inspection as needed.
- Coordinate and manage outsourced QC activities of late phase to commercial programs at CDMOs and / or contract testing labs (CTLs), including but not limited to in-process control test, final release test, and stability study.
- Manage quality events related to QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs.
- Author and/or review QC related documents, including methods, protocols, reports and memos.
- Manage method validation/transfer activities at CDMOs and / or contract testing labs (CTLs)
- Manage reference standards and reference materials including monitoring retest date, facilitating qualification/requalification, and tracking inventory.
- Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to timely achieve project goals.
Required Skills, Experience and Education:- BS or MS in Chemistry, Pharmaceutical Science or related discipline.
- 6+ years of relevant industrial experience in analytical development/QC.
- Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, QbD, process validation, manufacture sampling and testing, stability study, method validation and transfer, etc.
- Effective written and verbal communication skills and interpersonal skills.
- Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.
- Strong problem-solving skills with sound technically driven decision-making ability
- Excellent 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, Experience, and Education:- Commercial QC experience is preferred.
- Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.) is preferred. #LI-Hybrid #LI-CT1
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
$164,000-$205,000 USD
