Sr Director, Technical Fellow, ATSC MSAT (Duration-based role – 12 Months)
About The Position
This position is a duration-based role for 12 months, with the possibility of extension or conclusion based on business needs. The Sr Director Technical Fellow serves as a recognized technical leader and subject matter expert in cell therapy manufacturing and quality. This role drives strategic initiatives to strengthen process understanding, control strategies, and operational excellence across the CAR-T manufacturing network. It offers a unique opportunity to influence the future state of cell therapy manufacturing by advancing technical readiness for scale, enhancing compliance and inspection readiness, and delivering sustainable improvements that impact patient access to life-changing therapies. This highly visible position partners across manufacturing, quality, supply chain, development, and external stakeholders to develop data-driven strategies that improve process reliability, reduce risk, and support future growth. The successful candidate will play a critical role in shaping technical decisions, influencing executive leadership, and building durable organizational capabilities.
Requirements
- Minimum of 12 years of biotechnology, pharmaceutical, or related industry experience.
- Hands-on experience in manufacturing operations and/or research and development within a biopharmaceutical manufacturing environment.
- Experience supporting advanced therapy products, including cell and gene therapies, vaccines, or related biologics.
- Deep knowledge of T-Cell Biology
- Extensive knowledge of cell and gene therapy manufacturing processes.
- Advanced understanding of GMP requirements and quality considerations for commercial manufacturing.
- Strong knowledge of evolving global regulatory expectations and health authority requirements for Advanced Therapy Medicinal Products (ATMPs).
- Experience working collaboratively with contract manufacturing organizations and internal manufacturing sites.
- Demonstrated ability to lead complex, cross-functional initiatives within a matrix organization.
- Excellent analytical, problem-solving, communication, and stakeholder management skills.
Nice To Haves
- Master's degree or higher in a relevant scientific or engineering discipline.
- Recognized technical leadership within the cell and gene therapy industry.
- Extensive experience supporting commercial cell therapy manufacturing operations.
- Experience leading technical strategy across multiple manufacturing sites and functions.
- Experience supporting regulatory submissions, inspections, and health authority interactions.
- Demonstrated success developing and implementing risk-based process control frameworks.
- Strong track record of influencing senior leaders and driving enterprise-wide improvement initiatives.
- Relevant certifications are considered a plus.
Responsibilities
- Provide deep technical expertise in cell therapy process understanding, control strategies, and material handling practices to improve consistency, risk management, and manufacturing scalability.
- Lead cross-functional initiatives to strengthen process knowledge by integrating development data, comparability evidence, operational experience, and scientific insights into actionable business strategies.
- Drive the development and implementation of robust, risk-based control frameworks across manufacturing, quality, and supply chain functions to support compliant and inspection-ready operations.
- Lead technical evaluations of process performance, control strategies, and manufacturing data to identify opportunities for increased reliability and operational excellence.
- Provide technical leadership for complex manufacturing investigations, deviations, non-conformances, and root-cause analyses.
- Serve as a key scientific advisor to governance and leadership forums, clearly communicating technical risks, opportunities, and recommendations.
- Support global regulatory interactions, including submissions, inspections, technical documentation, and health authority inquiries.
- Collaborate with internal and external key opinion leaders to advance scientific understanding and strategic initiatives within the cell therapy space.
- Drive harmonization and standardization efforts across the manufacturing network to support future growth and scalability.
- Establish sustainable frameworks, tools, and ways of working that can be successfully transitioned to long-term organizational owners.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Director
