Director, Technical Fellow, ATSC MSAT (Duration-based role – 12 Months)
About The Position
This highly visible technical leadership role provides a unique opportunity to shape the future of cell therapy manufacturing by driving scientific understanding, manufacturing excellence, and patient impact across a global network. The Technical Fellow serves as a recognized subject matter expert in CAR-T manufacturing, quality control analytics, and T-cell biology, leading complex investigations and partnering across internal and external organizations to solve critical manufacturing challenges. This role is designed to bridge the gap between investigation execution and mechanistic root cause understanding, enabling faster resolution of manufacturing trends, reduction of product non-conformances, and improved patient access to life-changing therapies. The successful candidate will influence network strategy, support regulatory readiness, and serve as a scientific thought leader across the CARVYKTI manufacturing organization.
Requirements
- Minimum of a Bachelor’s degree is required.
- Minimum of 10 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 cell therapy, gene therapy, vaccines, biologics, or other advanced therapy medicinal products.
- Experience working with contract manufacturing organizations and/or global manufacturing networks.
- 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 therapies.
- Demonstrated ability to lead complex investigations and influence cross-functional stakeholders in a matrix environment.
Nice To Haves
- Master's, or PhD degree in Chemical Engineering, Microbiology, Cell Biology, Biotechnology, Biochemistry, or a related scientific discipline is preferred.
- Advanced expertise in statistical analysis, multivariate data analytics, and mechanistic modeling approaches.
- Experience leading network-wide technical or operational improvement initiatives.
- Experience supporting regulatory inspections and health authority engagements.
- Demonstrated success translating scientific findings into practical manufacturing solutions.
- Experience evaluating and resolving complex product quality, process performance, and manufacturing compliance challenges.
- Recognized technical expertise within cell therapy, gene therapy, or related advanced therapeutic modalities.
- Strong publication, presentation, and scientific communication skills.
Responsibilities
- Lead complex manufacturing trend investigations and provide deep scientific expertise to accelerate root cause identification and implementation of sustainable corrective actions.
- Design and execute advanced analytical approaches, including multivariate modeling, mechanistic hypothesis testing, and data-driven investigations to establish process and product quality relationships.
- Partner across MSAT, Manufacturing Operations, Quality Control, Data Science, and technical teams to develop a unified investigation and control strategy framework.
- Drive scientific understanding of manufacturing performance through analysis of complex process, analytical, and biological datasets.
- Support lifecycle management initiatives including technology transfer, process optimization, automation, and implementation of emerging manufacturing technologies.
- Provide technical support for regulatory submissions, health authority interactions, inspection readiness activities, and compliance-related assessments.
- Influence cross-functional and cross-organizational teams as a scientific thought leader while maintaining alignment with network quality, supply, and operational objectives.
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
- Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
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What This Job Offers
Job Type
Full-time
Career Level
Director
