Global specialty pharmaceutical/biotech company that develops, manufactures, and future commercialization of specialty pharmaceutical products. Areas of focus include oncology and rare diseases. The company’s core strengths include the product development and near commercialization of new products for the treatment of solid tumors.Work closely with several named institutions in the oncology research facilities.
- Plan and manage strategy for process design, optimization, scale-up, technology transfer and process troubleshooting for company pre-clinical and early phase clinical cell therapy products.
- Provide scientific and technical leadership for pre-clinical projects and projects in clinical development.
- Ensure that overall process development, technology transfer, optimization and product manufacture are in compliance with Food and Drug Administration (FDA) guidelines.
- Responsible for the successful tech transfer and troubleshooting of early phase process and analytics from academic partners or internal programs.
- Oversee the design and scale-up processes, instruments and equipment used to perform the process development and manufacturing functions.
- Reviewing technical data from clinical production batches as part of the ongoing product development activity to support Regulatory Filings. In addition, providing technical expertise to assist in trouble shooting issues during technical transfer or routine production.
- Hire, manage, and train staff. Plan and assign projects to meet departmental and organizational objectives. Provide guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance
- Develop the operations budget including capital requirements.
NOTE: deep process development experience desired but not a requirement.
- Advanced MS degree (PhD highly desirable) in relevant scientific discipline (such as Biotechnology, Immunology, Molecular Biology, Biochemistry), and significant prior experience in the manufacture of cell and gene therapies.
- Minimum 10 years of relevant experience in leadership and people management with successful performance track record.
- Strong understanding of cell and gene therapy, with knowledge and expertise in optimizing and scale up of cell therapy manufacturing processes.
- Proven track record in industry cell therapy manufacturing and process optimization.
- A deep understanding of and ability to apply of GMP/ICH/FDA regulations to product development strategy.
- Tech transfer and CMO management experience.
- Ability to lead successfully within extended, global multinational project teams and handle multiple challenges under pressure.
- Approximately 35% travel is required.
up to $220K+ plus 25% Annual Bonus + Equity Stock Options incentive
Houston, TX Area
AO - 4505