Senior Process Engineer I, Drug Product

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 critical role as the subject matter expert (SME) within Drug Product function, the position will be responsible for phase appropriate drug product including process development and optimization in supporting manufacturing, process scale up/tech transfer, and process validation as well as enabling readiness for commercial manufacturing of Revolution Medicines' compounds.

Responsibilities:

• Support drug product development and manufacture for RevMed compounds. Plan and coordinate the manufacturing activities of solid oral dosage tablet products, ensuring compliance with cGMP, FDA, and other regulatory requirements.

• Participate in identification, selection, and management of Contract Development and Manufacturing Organization (CDMOs) for formulation development and drug product manufacturing

• Monitor and optimize the performance, efficiency, and quality of the manufacturing processes, equipment, and systems.

• Troubleshoot and resolve any manufacturing issues or deviations, implementing corrective and preventive actions as needed.

• Support the technology transfer, scale-up, validation, and launch of new products or processes.

• Follow and maintain best practices, standards, and policies for manufacturing operations, ensuring compliance with safety, environmental, and ethical standards.

• Collaborate with cross-functional teams, including but not limited to Clinical Supply, Quality Assurance, Analytical Development and QC, Drug Substance, Project Management, Regulatory Affairs, and Research teams, to achieve project goals in a timely manner and assist in driving decision-making.

• Support end to end drug product development of NCE if applicable.

• Design and manage process development studies using a quality-by-design approach. Study and identify critical quality attributes (CQAs) and critical process parameters (CPPs) for drug products. Explore and establish proven acceptable ranges and control strategies for drug product manufacturing.

• Oversee execution of QbD and risk-based studies, as well as process development activities in preparation for registration, validation, and commercialization activities.

• Author/review technical reports and CMC related documents required for regulatory submissions.

• Travel to CDMO for the oversight of development activities and manufacturing (up to approximately 20%)

Required Skills, Experience, and Education:

• Ph.D. with 8 + years', or Masters' with 11 years of experience in the pharmaceutical/biotech industry with end-to-end drug product development and manufacturing experience of small molecules.

• Extensive knowledge and hands on experience in solid oral dosage tablet manufacturing, including formulation, granulation, compression, coating, packaging, and testing.

• Strong knowledge and understanding of cGMP, FDA, and other regulatory requirements for pharmaceutical manufacturing.

• Excellent capability to troubleshoot and resolve manufacturing issues.

• Hands-on experiences in late stage product development, scale-up, tech transfer and process optimization of solid oral dosage and parenteral formulations.

• Experiences in CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China

• Ability to work in a fast-paced, dynamic, and team-oriented environment.

Preferred Skills:

• Master's or Ph.D. degree in pharmacy, chemistry, engineering, or related field.

• Excellent written and verbal communication skills and interpersonal skills.

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.

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