This position will serve as the focal point for the day to day manufacturing of Hyperion’s commercial products. The successful candidate will be responsible for the oversight of commercial contract manufacturing organizations (CMOs). This technical-focused position requires hands on experience in product and process development, formulation development, and pharmaceutical dosage form manufacturing. This position reports into the Associate Director, Manufacturing and Development.
• Manage relationships with CMOs to ensure completion of ongoing manufacturing activities to meet commercial needs
• Work with internal partners and the CMO to troubleshoot manufacturing issues.
• Review batch production records (BPRs) to ensure cGMP documentation practices are followed and information entered is complete and accurate
• Write and/or amend SOPs, batch production records, qualification and validation protocols, reports and other documentation
• As necessary, review process, equipment, systems and utilities, qualification and validation protocols
• Lead technology transfer of existing commercial process to secondary CMOs.
• Inventory tracking management using integrated software.
• Drive changes in the process to increase efficiency.
• Primary liaison for managing the work product of third party vendors performing the above activities.
• Ability to travel to CMO sites for direct management when necessary.
• Travel ~10%
• BS degree in a scientific discipline; MS is a plus
• 5-8 years experience with the manufacturing of solid oral dosage forms
• Direct experience in managing CMOs/CROs of pharmaceutical products
• Experience in pharmaceutical manufacturing dosage form development, including both oral and parenteral products is a plus
• Demonstrated experience in pharmaceutical process and product validation, including packaging validation
• Working knowledge of analytical chemistry and regulatory and quality environments
• Ability to present study and program results to the project team members in a balanced fashion, addressing both technical and business drivers