What are the responsibilities and job description for the Senior Director, Drug Product position at Revolution Medicines?

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 drug product technical lead and CMC project lead, the position will be responsible for drug product development activities leading to NDA submission and commercialization, as well as development and execution of the CMC strategy. The individual will provide technical and project leadership, and work with cross-functional stakeholders to ensure pharmaceutical drug product development and CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines.

Lead drug product development activities to advance new chemical entities (NCE) from preclinical lead optimization stage through commercialization.
Lead preformulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization and process validation activities related to solid oral dosage and parenteral drug products.
Responsible for the development of strategies, overseeing the execution of technical activities associated with product development and manufacturing in support of clinical development, regulatory filings (IND / NDA / MAA), and product approvals and commercialization.
Design and 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.
Build and maintain a high performing team to support ongoing pipeline.
Strategic and technical oversight of internal staff and Contract Manufacturing Organizations (CMOs).
Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan / strategies.
Serve as a project core team member and communicate CMC strategy and project status to key stakeholder cross-functionally and assist in driving decision making.
Collaborate with cross functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to ensure CMC and program goals are met.
Travel to CDMOs for the vendor assessment and qualification, as well as manufacturing oversight as needed.

Required Experience, Skills and Education :

Minimum MSc degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable.

18 years of experience in the pharmaceutical / biotech industry with a sound track record of technical expertise and leadership, early and late phase drug product development experience of small molecules.

Exceptional problem solving. Demonstrated strong project and cross-functional team leadership, as well as people management skills.

Leadership experience in late-stage product development, scale-up, tech transfer and process optimization of solid oral dosage and parenteral formulations is a plus.

Thorough understanding and working experience of pharmaceutical drug product with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements.

Extensive experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China.

Strong problem-solving skills with strategic and sound technically driven decision-making ability.

Excellent written and verbal communication skills and interpersonal skills.

Innovative team-player with high energy for our dynamic company environment.

Preferred Skills :

Preferably a PhD in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable.

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Senior Director, Drug Product

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