Primarily responsible for the production of drug products intended commercial markets and clinical studies. Oversight of drug product manufacturing activities at contract manufacturing organizations.
Key Accountabilities/Core Job Responsibilities:
Provide technical review of batch records and associated documents for commercial drug products manufactured at the CMO. Function as technical expert to formulate solutions to complex manufacturing issues. Collaborate with internal quality organizations to enable timely lot release and issue resolution.
* Interact with the supply chain group at Pharmacyclics to monitor and direct the drug product production schedule in accordance with the supply forecast.
* Create and maintain manufacturing database and lead continued process verification efforts. Compile and interpret intra- and inter- batch data to assess variability and formulate strategies to minimize and improve process control.
* As necessary, function as Person-In-Plant to oversee GMP manufacturing operation performed at CMO site. Formulate solutions to complex manufacturing issues.
* Solid background in solid dosage form manufacturing processes. Experience in managing CMO’s required.
* Thorough understanding of regulatory guidance as applied to solid dosage forms and cGMP.
* Excellent organizational and time management skills. Team Player.
* Advanced communication and technical writing skills.
* Strong strategic planning ability as well as detail-oriented thinking required.
* 5+ years of relevant experience in the pharmaceutical industry. Level and salary commensurate with experience.
Education Requirements (degree, certifications, etc.): Include must have and preferred
BS in a scientific discipline.