Director, Process Development, Manufacturing Sciences & TechnologyUnited States - Maryland - FrederickProcess/Product Development & OperationsRegular
We are seeking a highly motivated individual to join us in the Manufacturing Sciences & Technology (MSAT) group, as a Director of MSAT reporting to the Site Head of Manufacturing Science and Technology. In this role you will have a key leadership position within Kite's Process Development (PD), Global MSAT and Technical Operations functions, and will be responsible for leading a team to support the clinical and commercial manufacture of cell therapy products. This position will require collaboration with site operations, Facilities and Engineering, IT, Supply Chain and Quality to ensure manufacturing robustness and proper adoption of tech transfers to the site. This is a highly visible position that will require superb critical thinking, communication, negotiation and multi-functional influence abilities, as well as knowledge of the business. You will work closely with various Global Tech Ops functions including Supply Chain and Quality to ensure successful decision making through Technical Operations Governance systems.
The ideal candidate should have experience in the area of cell therapy, technology transfers, GMP manufacturing, and an excellent understanding of global regulations.
- Lead the manufacturing site MSAT group to support clinical and commercial manufacture of cell therapy products.
- Provide strategic MSAT leadership and direction aligned with Process Development, Global Manufacturing, Supply Chain, Multi-functional Operational Team and Global Technical Operation’s vision, mission and goals.
- Mentor Process Engineers and Scientists on Cell Therapy Manufacturing Technologies, Process Improvement projects and GMP manufacturing.
- Lead the site Validation activities to ensure Right First Time Technology Transfer.
- Work with MSAT lab on site to lead troubleshooting for manufacturing and ensuring manufacturing robustness of new technologies.
- Collaborate with site functions to ensure process robustness.
- Work with Global Regulatory and GMSAT to provide technical support to regulatory filings and health authority questions.
- Mentor staff. Develop leaders by providing an environment that encourages ongoing personal and professional development.
- Work to build a positive culture with key partners and customers in Process Development, Operational Team, Global Manufacturing, Supply Chain, Quality, and other external Tech Ops partners.
- PhD in Biochemical Engineering, Biotechnology or Life Sciences with 8+ years of biotech experience.
- Masters’ Degree in Biochemical Engineering, Biotechnology or Life Sciences with 10+ years of biotech experience.
- Bachelors’ Degree in Biochemical Engineering, Biotechnology or Life Sciences with 12+ years of biotech experience.
- HS Diploma and 16+ years of biotech experience.
- Cell therapy experience desired.
- Demonstrated leadership experience in building highly collaborative and sustaining strong performing teams, and leading technical leaders.
- Proven track record of leading a Technology organization supporting GMP manufacturing and/or Process Development .
- Strong knowledge of GMP compliance, regulations and manufacturing operations.
- Experience in cell culture, aseptic processing, and use of single use system and automation technologies.
- Excellent understanding of process engineering/validation and comparability.
- Self-motivated, problem-solving, critical thinking, negotiation and multi-functional influence abilities, and business process improvement and excellent prioritization skills.
- Ability to manage budget and resource management.
- Excellent 360-degree communication skills.
- Knowledge of QbD and/or Six Sigma is a plus.