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Manager/Sr.Manager, Quality Control and Stability Management, Analytical Development – CMC
at Revolution Medicines in California
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value 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 critical role as the subject matter expert (SME) on stability management and quality control operations within Analytical Development - CMC, the position will be mainly responsible for managing stability programs and reference materials, maintaining cGMP-compliant quality control operations and documentation in support of Revolution Medicines pipeline compound development and clinical programs.
Responsibilities:
Coordinate stability activities, including but not limited to monitor schedule, data entry, trending, review and presentations/reports
Track stability studies, maintain stability database
Oversee outsourced stability studies at CDMOs and or contract testing labs
Manage quality events related to stability studies such as lab investigation, deviations, change controls, CAPAs
Author and / or review stability related documents, including protocol, report, and memos
Manage reference materials including monitoring retest date, facilitating qualification/requalification, tracking inventory
Provide support to quality systems and documentation as needed
Collaborate with cross functional teams including Process R&D, Pharmaceutical Development, Toxicology, and Quality Assurance to timely achieve project goals
Education, Experience and Skills Requirement:
BS or MS in Life Sciences, Chemistry or related discipline
6+ years of relevant industrial experience in analytical development/QC with 2+ years experience managing stability studies
Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to stability study in small molecule drug development
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
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.
Reference : Manager/Sr.Manager, Quality Control and Stability Management, Analytical Development – CMC jobs
Reference : Manager/Sr.Manager, Quality Control and Stability Management, Analytical Development – CMC jobs
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Published at 07-09-2022
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Viewed: 484 times