Playing a critical role as the subject matter expert (SME) of Drug Product team within the Pharmaceutical Development and Manufacturing (PDM) function, the position will be responsible for drug product development and manufacturing with focused on formulation and process optimization, clinical batch production, scale-up development and process validation in support of RevMed pipeline compounds development and eventual commercialization.

Responsibilities:

• Support drug product development and manufacturing activities to advance new chemical entities (NCEs) from clinical development to commercialization.
• Support and/or lead formulation and process development, clinical manufacturing, scale-up, technology transfer, process validation and packaging of solid oral drug products at CDMOs.
• Manage GMP manufacturing of drug products to support clinical studies, stability, and process validation, including production timeline, raw materials inventory, etc.
• Prepare, review, and approve manufacturing batch records, campaign reports, development study protocols and reports. Perform data review of batch records and summarize batch production history. Assist preparation of CMC regulatory submission documents.
• Support and manage process development studies using a quality-by-design approach. Study and identify critical quality attributes and critical process parameters for drug product. Explore and establish proven acceptable range and control strategy for drug product manufacturing.
• 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 team, to achieve project goals in a timely manner.
• Travel to CRO/CDMO sites for the oversight of development and manufacturing activities (up to 10%).

Required Experience, Skills and Education:

• A graduate degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field is desirable.
• Preferably MS with 5+ years or PhD with 2+ years of experience in the pharmaceutical/biotech industry with drug product development and manufacturing experience of small molecules.

• Experience in formulation and process development, DOE study, technology transfer, process scale-up, clinical manufacturing and primary packaging of solid oral drug products.

• Familiar with pharmaceutical analytical techniques to support drug product development and manufacturing.
• Knowledge and understanding of current ICH guidelines, GMP regulations, quality systems, and related industry practices for pharmaceutical development.

• Working experience in managing development and manufacturing activities at CDMOs.
• Excellent communication (both verbal and technical) and problem-solving skills.
• Ability to multi-task and thrive in a fast-paced innovative environment.

Preferred Skills:

Experience in enabling formulation development, spray dried dispersion, roller compaction, tablet compression, and coating are preferred.

The base salary range for this full-time position is $128,000 to $160,000 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.