- Plan, direct, and coordinate the manufacturing activities of solid oral dosage tablet products, ensuring compliance with cGMP, FDA, and other regulatory requirements.
- 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.
- Lead and support the technology transfer, scale-up, validation, and launch of new products or processes.
- Manage the manufacturing staff, contract manufacturing sites, providing training, coaching, feedback, and performance evaluation.
- Develop and manage the manufacturing budget, ensuring cost-effectiveness and profitability.
- Collaborate with cross-functional teams, such as R&D, engineering, quality, supply chain, and sales, to ensure alignment and coordination of manufacturing goals and objectives.
- Implement and maintain best practices, standards, and policies for manufacturing operations, ensuring compliance with safety, environmental, and ethical standards.
- Stay updated on the latest trends, technologies, and innovations in the pharmaceutical industry, especially in the field of solid oral dosage tablet manufacturing.
- Lead end to end development of NCE if applicable.
- 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 on going pipeline.
- Provide strategic and technical oversight of internal staff and Contract Manufacturing Organizations (CMOs).
- Lead cross-fucntional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan / strategies.
- Bachelor's degree in pharmacy, chemistry, engineering, or related field. Master's degree or Ph.
- Minimum +15 years of experience in pharmaceutical manufacturing, with at least 5 years in a leadership role.
- Extensive knowledge and hands on experience in solid oral dosage tablet manufacturing, including formulation, granulation, compression, coating, packaging, and testing.
- Strong product launch track record.
- Strong knowledge and understanding of cGMP, FDA, and other regulatory requirements for pharmaceutical manufacturing.
- Excellent analytical, problem-solving, and decision-making skills, with the ability to troubleshoot and resolve complex manufacturing issues.
- Strong leadership, management, and communication skills, with the ability to motivate, inspire, and influence others.
- Leadership experience in late stage product development, scale-up, tech transfer and process optimization of solid oral dosage and parenteral formulations.
- 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.
- Ability to work in a fast-paced, dynamic, and team-oriented environment.
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Senior Director, Drug Product - Redwood City, United States - Revolution Medicines, Inc.
Description
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.
Required Experience, Skills and Education:
An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics.
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.
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
Senior Director, Drug Product professionals in Redwood City
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Mark Davoren
Senior Sales Development Leader