Senior Director – Process Design-Autologous Cell Therapy

Senior Director – Process Design-Autologous Cell Therapy

Requirements

• Knowledge across multiple manufacturing technologies used for cell and gene therapy including viral and non-viral genome engineering technologies.
• Experience with both autologous and allogeneic cell therapy manufacturing workflows is desirable.
• Excellent data analysis experience with a variety of scientific software applications.
• Proficient in experimental design with the ability to document laboratory procedures and experiments.
• Demonstrated leadership and people management capabilities in driving change; can guide appropriate dialogue at the senior level to escalate and resolve issues.
• Builder and team leader – sought out by others as a coach.
• Summarize scientific results in a concise manner to both technical and non-technical audiences.
• Willing to accept responsibilities outside of initial job description.
• Distill complex information in a concise, logical, and audience appropriate manner.
• A minimum of 14 years with BS/BA; 12 years with MS/MA or ten (10) years Phd in biochemistry, biochemical engineering, or related field.
• A minimum 10 years of experience, leading teams of people (leading leaders) across multiple geographic locations (approximately 25 % travel required).
• Demonstrated experience developing and establishing process strategies required for early, late, cell therapy processes.
• Experience with integration of process control strategies with understanding of attribute sciences.
• Experience with metabolomics and CT characteristics as it relates to production technology.
• Experience with analytical techniques used to characterize and measure CT approaches.
• Experience partnering with CMC teams to define and deliver tech strategy required for product development.
• Experience partnering externally on product development.
• Understanding of enterprise network strategy and development execution impact on P&L.

Responsibilities

• Lead all cell therapy DP process development activities and teams across multiple sites.
• Develop and implement cost-effective processes for autologous cell therapy approaches.
• Develop phase appropriate first in human processes to ensure speed on portfolio delivery.
• Develop global strategy and implementation of DP process strategy aligned with the internal operations network and commercial considerations for CT.
• Provide technical oversight of CT process related investigations at internal and external manufacturing sites in collaboration with MSAT Team.
• Lead enterprise assessment of novel technologies including automation.
• Build teams. Develop world class scientific, technical and engineering talents and create an environment where they can excel.
• Create partnerships to evaluate and evolve the department’s strategy to ensure agreement on our goals while balancing cost, time and speed.
• Be a member of the Process Sciences, Analytics and Technology leadership team, participating in CMC program review and governance meetings and providing guidance for best practices and direction for continuous improvement.
• Review regulatory CMC submissions to ensure their quality and technical content.

Preferred Qualifications

• Experience with both autologous and allogeneic cell therapy manufacturing workflows is desirable.