Reports To: Vice President, Chemistry and Manufacturing
The Director / Senior Director of API Development and Manufacturing will lead the development efforts for our drug substances. He/she will work through contract manufacturers to develop processes, schedule production and create strategies to ensure meeting clinical timelines, regulatory requirements and commercial expectations. This position will report to the Vice President of Chemistry and Manufacturing.
Essential functions include but are not limited to the following:
- Provide project leadership and technical oversight for development of small molecule APIs through contract manufacturers (CMOs)
- Coordinate activities to ensure a supply of API to meet preclinical and clinical requirements
- Develop a manufacturing process to meet the commercial demands and development timelines of our products
- Develop a supply chain plan to ensure current and future demands
- Work with Analytical, Quality Assurance and Regulatory to develop appropriate control requirements for the drug substance
- Represent API issues within CMC group and cross functional teams
- Directly monitor manufacturing operations at the CMO sites as needed to understand and respond to real-time issues
- Travel 20-50% time depending on location
- Ph.D. in Physical/Organic Chemistry or Chemical Engineering preferred, B.S./M.S. in Chemical Engineering with relevant industry experience
- Working knowledge of cGMPs and validation methodologies for drug substances
- Direct experience with management of CMOs
- 10 years experience in small molecule API development including process research, development and validation
- Strong organizational skills and ability to effectively manage multiple priorities and projects
- Good written and verbal communication skills
- Ability to travel domestically and internationally
Human Resources
Medivation, Inc.
201 Spear Street
3rd Floor
San Francisco, CA 94105
hr@medivation.com
