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Revolution Medicines · 2 days ago
Vice President, Analytical Development & QC
Redwood City, CA
Full-time
Onsite
Executive
$265K/yr - $350K/yr
18+ years exp
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Responsibilities
Lead analytical development and operations from early to late development through commercialization
Be accountable for analytical related development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals and commercialization
Author/review/approve the relevant CMC sections to enable global regulatory filings
Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
Serve as a project core team member and communicate CMC strategy and project status to the key stakeholder cross-functionally and assist in driving decision-making
Collaborate with cross functional teams (drug substance, drug product, supply chain, quality, CMC regulatory, CMC PM, Clinical, DMPK and tox, as well as program management) to ensure CMC and program goals are met
Lead the efforts to assess / identify potential suppliers for analytical development and QC activities in support of drug substance and drug product development and manufacturing with adequate risk assessment
Travel to CDMOs and/or CTLs for the vendor assessment and qualification, as well as analytical activities oversight as needed
Qualification
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Required
Minimum MSc degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field
18 + years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership, early and late phase analytical development and operations experience of small molecules with commercial experience a plus
Extensive experience in late phase innovative drug development and commercial launch with global CMC regulatory filings (IND/NDA/MAA, etc.)
Proven track record of strategic leadership and management with at least 10 years in the management role
Demonstrated strong project and cross-functional team leadership, as well as people management skills
Thorough understanding and working experience of innovative drug development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements
Extensive working experience with management and oversight of the analytical activities at CDMOs and/or CTLs
Strong problem-solving skills with strategic and sound technically driven decision-making ability
Effective written and verbal communication skills and interpersonal skills
Innovative team-player with high energy for our dynamic company environment
Preferred
Preferably a PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field is desirable
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
51-200 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (14)
2022 (7)
2021 (2)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.25BKey Investors
Boxer CapitalNextech InvestThird Rock Ventures
2023-03-02Post Ipo Equity· $323.6M
2022-07-19Post Ipo Equity· $264.5M
2021-02-03Post Ipo Equity· $260.9M
Leadership Team
Mark A. Goldsmith
Founding President & Chief Executive Officer
Luan M. Wilfong
Chief Human Resources Officer
Recent News
Investor's Business Daily
2024-06-04
2024-05-19
Company data provided by crunchbase
