- Provide supports to stability program management, quality systems and QC documentation (e.g. SOPs) and PAI readiness and inspection as needed.
- Lead and/or coordinate QC activities of late phase and commercial programs, including but not limited to commercial launch readiness, in-process control test and final release test.
- Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs).
- Manage quality events related to commercial 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 commercial QC related documents, including methods, protocols, reports and memos.
- Manage commercial phase 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.
- BS or MS in Chemistry, Pharmaceutical Science or related discipline.
- 10+ years of relevant industrial experience in analytical development/QC with 5+ years Commercial QC experience.
- Solid understanding of relevant global and regional regulatory guidelines (FDA, EU, and ICH, etc.) as applicable to QbD, commercial process validation, commercial product launch, commercial manufacture sampling and testing, and post-approval quality control requirements.
- Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.).
- 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.
- Effective written and verbal communication skills and interpersonal skills.
- 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.
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Associate Director, Analytical Development - Redwood City, CA, United States - Revolution Medicines, Inc.
Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
Playing a project leading role and Subject Matter Expert (SME) of late phase and commercial Quality Control within Analytical Development & QC, PDM department. In support of RevMed clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to commercial launch readiness supports of drug substance (DS), drug product (DP) and final product (FP) manufacturing. The candidate will also be responsible for post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.
The Opportunity
Required Skills, Experience, and Education:
Preferred Skills, Experience, and Education:
The expected salary range for this role is $160,000 to $200,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact
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