Playing a leading role and Subject Matter Expert (SME) of Quality Control within the PDM Analytical Development & QC department in support of RevMed clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to commercial manufacture of drug substance (DS), drug product (DP) and final product (FP). The candidate will also participate in post-approval QC-related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.

• Provide support to 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 tests, final release tests, 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 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.

Education, Experience and Skills Requirement:

• BS or MS in Chemistry, Pharmaceutical Science or related discipline.
• 6+ years of relevant industrial experience in analytical development.
• 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:

• Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.).
• QC with Commercial QC experience.

The base salary range for this full-time position is $135,000 to $175,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary 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.