Provide technical leadership and oversight for successful execution of all manufacturing activities associated with Pharmacyclics active drug substances at contract manufacturing organizations (CMOs) in China. The role involves monitoring manufacturing activities on site, potentially for several weeks at a time, at contract manufacturing organizations to ensure on-time delivery of products produced under GMP for late phase clinical studies and commercial distribution. Candidate must be highly experienced with large scale pharmaceutical manufacturing (batch and continuous process), have and maintain a full working knowledge of GMP requirements of multinational regulatory authorities, and be experienced with project management principles to monitor and ensure CMOs deliver products according to Pharmacyclics commercial needs and timelines. The candidate must also be able to work independently while in China as well as collaboratively with CMC, Quality, and Regulatory personnel within Pharmacyclics to ensure products are produced in a compliant manner. This will require effective English skills, both written and spoken.
Education and Experience
- Provide technical and managerial oversight of drug substance production at CMOs to ensure ongoing production to support clinical and commercial demand in accord with GMP standards and ICH Guidelines.
- Ensure that potential manufacturing risks are effectively identified, communicated, and mitigated.
- Prepare written reports in English and help CMOs prepare well written documentation for review by Pharmacyclics
- Support manufacturing process validation efforts and maintain processes in a state of validation
- Support the manufacturing product launch by ensuring practical, cost effective and compliant manufacturing.
- Bring extensive knowledge of manufacturing processes utilized by the pharmaceutical industry.
- BS or MS in Chemistry or Chemical Engineering
- Extensive and ongoing (yearly) training in current Good Manufacturing Practices
- 10+ years experience in pharmaceutical manufacturing, drug substance manufacturing preferred
- Good knowledge and understanding of Good Manu facturing Practices for drug substances
- Experience in process validation and maintenance of validated manufacturing processes
- Experienced in development of small molecule drugs
- Experience managing Contract Manufacturing Organizations
- Ability to speak, read and write, as well as understand spoken English a must
- Ability to read, write and speak Mandarin a plus
Pharmacyclics, Inc. - 21 months ago