This position reports to the Vice President, Manufacturing and supports the company’s oncology programs. The Director/Senior Director, Drug Substance (API) Manufacturing will provide expertise and leadership for the manufacture of Geron’s imetelstat oligonucleotide using our proprietary nucleic acid chemistry.
The Director/Senior Director Drug Substance (API) Manufacturing will lead the drug substance manufacturing function in developing and executing CMC strategies across the product life cycle for an oligonucleotide therapeutic, including manufacturing, process development and technology transfer to ensure that processes and products are manufactured in compliance with all regulations and guidelines to support late-stage clinical studies, product licensure, and commercialization.
- Oversight and direction of Geron’s drug substance (API) contract manufacturers and raw material suppliers. Develop and maintain relationships with these vendors.
- Develop and maintain batch records, systems, procedures and associated documentation in coordination with vendors as well as Geron Quality Assurance, Quality Control and other functional areas.
- Person-in-plant support as needed to oversee production activities.
- Process design, development and validation of the manufacturing process.
- Analysis and trending of manufacturing results and outcomes.
- Author reports and other documentation necessary during the product life cycle.
- Prepare and manage to budgets, project plans and timelines.
- Transition the manufacturing program from Phase 2/3 to commercial.
- Collaborate closely with projects teams to ensure and manage the appropriate projects plans and timelines for the preparation of team deliverables.
- Provide insight into potential risks and benefits of Geron’s project plans and recommend alternatives.
- Support regulatory interactions and submissions with various global regulatory agencies.
Education and Experience Requirements
- Seasoned, senior level Manufacturing professional sought, with 10+ years demonstrated experience manufacturing oligonucleotides.
- Bachelor’s degree (preferred in organic chemistry) in relevant field.
- Direct experience working with or for contract manufacturing organizations.
- Extensive oligonucleotide synthesis and purification experience.
- Experience with analytical methods such as NMR, HPLC, MS, LC-MS, and CGE.