Senior Manager, Analytical Development & Quality Control (San Francisco) Job at Revolution Medicines, San Francisco, CA

WlpEL0hHRVZSZDVnQjc0eGxCNFMxa0s5M2c9PQ==
  • Revolution Medicines
  • San Francisco, CA

Job Description

Senior Manager, Analytical Development & Quality Control

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.

The Opportunity:

Playing a leading role and Subject Matter Expert (SME) of Quality Control within 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 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 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 in solid oral dosage including dissolution testing.
  • Commercial QC experience is preferred.
  • Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.) is preferred.
  • Chromatographic experience in development, optimization, and troubleshooting.

The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. 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.

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 privacy@revmed.com .

Seniority level

  • Seniority level

    Mid-Senior level

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Research and Science

Referrals increase your chances of interviewing at Revolution Medicines by 2x

Get notified about new Manager Analytical Development jobs in San Francisco Bay Area .

Novato, CA $121,600 - $167,200 3 weeks ago

Sunnyvale, CA $116,000 - $160,000 2 weeks ago

San Jose, CA $170,000 - $182,750 4 weeks ago

Pleasanton, CA $160,000 - $202,500 1 week ago

Scientist I/II, Analytical Development (Contract to Hire)

South San Francisco, CA $64 - $79 2 weeks ago

Principal Scientist, Small Molecule Analytical Sciences

Scientist, Analytical Development and Quality Control

Senior Scientist, Formulation Fill/Finish

Brisbane, CA $160,164 - $213,972 1 week ago

Sr. Scientist, Small Molecule Analytical Sciences

Senior Scientist I (Analytical Chemistry)

Alameda, CA $116,000 - $165,500 2 weeks ago

Senior Principal Research Scientist, Analytical Chemistry

Scientist, Analytical Development (I,II,III)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

Job Tags

Full time, Contract work, Work experience placement, Local area,

Similar Jobs

Capital One Careers

Senior Associate Level Product Designer - eData.xd Job at Capital One Careers

Senior Associate Level Product Designer - eData.xd We are currently seeking a UX Designer to join our team. We are passionate about advocating for user needs and delivering world-class products that redefine our customers day-to-day financial activities. The... 

AccentCare

Home Health Certified Occupational Therapy Assistant Job at AccentCare

 ...Job Description AccentCare is seeking a Home Health Certified Occupational Therapy Assistant for a job in Temple, Pennsylvania. Job Description & Requirements ~ Specialty: Certified Occupational Therapy Assistant ~ Discipline: Therapy ~ Duration: Ongoing... 

InRhythm

Director of Marketing - Tech Consulting Job at InRhythm

 ...live and work, and think in a positive way. An Inc. 5000 hall of fame Fastest Growing Company for 9 years, Deloitte Fast 500 company for 5 years, and Consulting Magazine Fastest Growing Company winner several years in a row, we look forward to continuing to expand with... 

Manpower

Automatic Screw Machine Machinist - Macon, MO - FOUR DAY WORK WEEKS! Job at Manpower

 ...period associates are eligible for: ~ Medical and Prescription Drug Plans~ Dental Plan~ Supplemental Life Insurance~ Short Term Disability Insurance~401(k) If this is a role that interests you and you'd like to learn more, click apply now and a... 

Disability Solutions

Residential Life Coach Job at Disability Solutions

 ...Description Empower Lives on the Move as a Residential Life Coach at Ability Beyond! Locations: Danbury, Ridgefield, and New Milford, CT Pay Rate: $19.00 - $19.50/hour Schedule: Full-Time Day and Evening Shifts Available About Ability Beyond:...