Working with the Associate Director, Manufacturing and Development, this position will facilitate ongoing commercial manufacturing activities and the development of clinical phase candidates. The candidate will contribute to and track the development and execution of technical studies in support of Hyperion development, clinical, and commercial products. The Associate will be responsible for the communications with third party vendors involved in the execution of Hyperion development studies and clinical products. This technical-focused position requires hands-on experience in product and process development, formulation development, and pharmaceutical dosage form manufacturing.
• Work with third party labs and vendors to generate and execute development studies aimed at troubleshooting manufacturing problems, developing new dosage forms, and supporting new indications or field uses of existing products.
• Work with the Associate Director to draft, implement, and report on development studies in support of Hyperion development, clinical, and commercial products.
• In collaboration with the Associate Director, coordinate with Hyperion CMOs to schedule manufacturing.
• Track and monitor supply materials for clinical trials.
• Track drug product requests for investigator initiated studies and compassionate use.
• Identify and communicate possible issues in the manufacturing schedule
• Track project progress against partner invoices and against issued POs
• Maintain and organize manufacturing folder
• Review SOPs, batch production records, qualification and validation protocols, reports and other documentation
• 3+ years of experience in pharmaceutical operations and development
• Degree in a scientific discipline
• Demonstrated experience in pharmaceutical process and product validation
• Working knowledge of analytical chemistry and regulatory and quality environments