Director, Drug Substance
$211k - $264kRevolution Medicines
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.The Opportunity:Playing a critical role as a technical lead within the Drug Substance function, the position will be responsible for process research and development and scale-up of manufacturing in support of Revolution Medicines’ pipeline compound development, clinical programs and commercial readiness. Responsibilities:Responsible for developing chemical processes for the manufacture of drug substance, intermediates and/or starting materials, including route evaluation and process optimization.Conduct process development and optimization studies according to the principles of quality by design (QbD), to enable regulatory starting materials designation, establish control strategy and process characterization studies using tools such as design of experiment (DOE) studies.Lead and/or enable technology transfer, process familiarization, and manufacturing at CDMOs.Participate in identification, selection, and management of CROs and CDMOs including management of redundant supply and geographic diversity.Write, review, and approve protocols, manufacturing batch records, and development and campaign reports.Author, review the relevant CMC sections of regulatory filings and patent applications.Partner with analytical development, pharmaceutical development, and supply chain functions to design overall strategy for programs.Communicate effectively within cross functional project teams.Travel to CRO/CDMO for the oversight of development activities and manufacturing (up to approximately 15%).Required Skills, Experience and Education:PhD (minimum MSc degree) in organic chemistry, chemical engineering or related discipline.10 or more years (15+ years for Master’s degree) of relevant industrial experience in chemical / drug substance process research and development.Strong people management skills.Hands-on proficiency in synthetic organic chemistry.Knowledge of current ICH guidelines, GMP, and relevant industry practices.Working experience and knowledge of regulatory submissions (IND, IMPD, NDA and MAA).Previous experience managing projects at CROs/CDMOs.Strong problem solving skills with sound technically driven decision-making ability.Effective written and verbal communication skills and interpersonal skills.An innovative team-player with high energy for our dynamic company environment. #LI-Hybrid #LI-CT1The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.Please note that base pay salary range 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 View email address on us.fitly.work Pay Salary Range$211,000—$264,000 USDWe are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to View email address on us.fitly.work so we can share these impersonations with our IT team for tracking and awareness.
$210k - $245k
...commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.Summary:The Director for Drug Substance (DS) Commercialization of Conjugation will lead and facilitate launch readiness and commercial supply of glycoconjugate...SuggestedRemote work- Revolution Medicines seeks a Senior Supplier Management Lead for Drug Substance within the PDM function. You will oversee the global network of Drug Substance and raw material CMOs, drive CMO lifecycle programs, and lead cross-functional teams to ensure on-time start-up...Suggested
- ...Redwood City, CA, and seeks an experienced professional to support analytical development activities for drug substances and products, reporting to the Sr. Director of Analytical Development and Quality Control. You will collaborate with CMOs, review GMP documentation,...Suggested
$170k - $200k
...based in Redwood City, CA, is looking to hire an Associate Director of Program Management . Codexis is a leading enzyme engineering... ...: Manage client programs to manufacture siRNA drug substances and oversee projects through scale-up at CDMO and future clinical...SuggestedTemporary workSummer holidayFlexible hours$164k - $205k
...patients.Revolution Medicines is seeking an experienced and strategic leader to serve as Senior Manager, Commercial Manufacturing, Drug Substance within the PDM organization. This individual will play a critical role in advancing/supporting the company’s API commercial...SuggestedFull timeLocal areaWorldwide- Revolution Medicines is seeking a Senior Manager, Commercial Manufacturing, Drug Substance to lead external API manufacturing programs within the PDM organization. You will oversee technology transfers, CPV, and lifecycle management across late-stage development and commercial...
$186k - $233k
...high standard of rigor—all in service of patients.The Opportunity: Associate Director QC will be responsible for oversight of the Quality Control testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios...Full timeContract workWork experience placementLocal areaWorldwide$200k - $215k
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...to join Vaxcyte's Global Analytical organization as Associate Director, CMC Statistician. The position will be an integral part of... ...for the VSWG, supporting specification-setting strategy for drug substance, drug product, intermediates, raw materials, release testing,...Remote work$180k - $200k
...Associate Director/ Director, Supply Chain Management Synthekine is a Menlo Park, CA based biotechnology company focused on discovering... ...inventory planning, domestic and international shipping of drug substance and drug product, DS/DP product logistics, labeling and...Work at officeLocal area$50 - $60 per hour
Principal Scientist/Associate Director, Clinical Biomarkers Principal Scientist/Associate Director... ...actionable biomarker strategies across drug development stages, consistent with... ...Quality Control Scientist, Small-Molecule Drug Substance Development and Manufacturing Medical...Full timeRelocation package$182.07k - $235.62k
...come. Key Responsibilities: The Associate Director, Strategic Sourcing & Supplier Management, Sterile Drug Product and Biologics owns the strategic... ...small molecule sterile drug product, biologics drug substance and drug product, and antibody drug conjugates to...Full timeContract workFor contractorsLocal areaRemote work2 days per week- ...Job Description Attovia Therapeutics, Inc., is seeking a Director of CMC management to lead CMC regulatory strategy, submissions... ...regulatory filings, providing technical guidance to CDMO on drug substance and drug product development and manufacturing, and ensuring...
- ...Therapeutics in Newark, CA is seeking to lead the Screening and Automation team within our Biology and Translational Science unit to automate drug discovery assays. You will build and mentor a scientific team, create strategies for laboratory automation, implement new automation...
$186k - $233k
...leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in overseeing clinical trials. As an Associate Director, you will be responsible for the Contract Research Organization (CRO) oversight...Full timeContract workWork at officeLocal areaWorldwide$180k - $210.5k
...discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience... ..., EMA, Health Canada and ICH) guidelinesReports to: Executive Director, CMC RegulatoryLocation: San Carlos, CA / US RemoteWork...$229.3k - $269.8k
...City, California. To learn more, visit As an Associate Medical Director, you will support the ongoing and planned execution of the Oncology... ..., develop and, implement clinical studies for the applicable drug candidate, from Phase I through Phase III Develop and participate...Full time$186k - $233k
...patients.The Opportunity:Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within... ...regulatory requirements (minimally US FDA) regarding applicable drug development regulations.Effective communication (verbal and...Full timeLocal areaWorldwide$229.3k - $269.8k
...headquartered in Redwood City, California. To learn more, visit As a member of the Statistical Programming team, the Associate Director is responsible for the planning, execution, and quality of SAS programming to conduct statistical analyses in support of clinical...Full time$186k - $233k
...act with urgency and hold ourselves to a high standard of rigor-all in service of patients. The Opportunity: The Associate Director, Business Operations is an internal project manager with a consultant mindset and hands-on approach. This is an execution-focused...Full timeLocal areaWorldwide$161k - $227.5k
...condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease...Full timeContract workFor contractorsFor subcontractorWork at officeLocal areaRelocation package- ...right treatments for the right patients, at the right time.The Director of Epidemiology & Methodological Innovation will lead high-impact... ...non-linear data into regulatory-grade insights that accelerate drug development and improve patient outcomes.Key ResponsibilitiesMethodological...Full timeRemote work
$211k - $264k
...identify and characterize high-priority oncology targets for our tri-complex inhibitor (TCI) platform. We are looking for an experienced drug hunter to lead the Target Biology team, provide hands-on scientific and people leadership, and work cross-functionally to identify...Full timeLocal areaWorldwide$244k - $305k
...informed development decisions and global regulatory filings. The successful candidate will:Lead nonclinical safety strategy for multiple drug development programs spanning both small molecules and biologics.Serve as the toxicology representative on cross-functional Research...Full timeLocal areaWorldwide- Dyna Robotics builds general-purpose robots powered by a proprietary embodied AI foundation model with top-in-industry generalization and real-world performance. Already deployed with customers across multiple industries, our robots do commercial-grade work in the physical...Hourly payFull timeShift work
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About Periodic Labs The most important scientific discoveries of our time won’t happen in a traditional lab. We’re an AI and physical sciences company building state-of-the-art models to accelerate breakthroughs across materials, energy, and beyond. Backed by world-class...Full timeVisa sponsorshipFlexible hoursDay shift$186k - $233k
...rigor—all in service of patients.The Opportunity:The Associate Director, Global Regulatory Affairs Project Management is an integral part... ...to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs. The role partners...Full timeWork at officeLocal areaWorldwide$215k - $235k
Earli tackles the #1 problem in the $100B cancer drug market: systemic toxicity. On-target/off-tumor effects force suboptimal dosing,... ...through who you are The Position Earli is currently seeking a Senior Director, In Vivo Pharmacology to oversee and lead the In vivo/...Local area$183.5k - $269.8k
...diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit The Associate Director of Biostatistics will be responsible for leading the execution of statistical components of Corcept Development programs. This...Full timeFor contractors3 days per week$211k - $264k
...Contribute to the development of functional-level standards, SOPs, and templates. Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members. Required Skills, Experience...Full timeLocal area
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