Executive Director, Cell Therapy Technical

3 weeks ago

Summit, United States Bristol-Myers Squibb Full time

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

The Executive Director of Cell Therapy Vector Operations will report to the Vice President of CTTO. This role is a key leadership position within the BMS CTDO Division as we prepare to commercialize autologous cellular biologics to overcome tumor evasion and potentially eradicating cancer cells. The role will lead a global team of ~30 technical leaders and process engineers and continuing to grow as we expand our manufacturing footprint and global supply chain. The Vector CTTO team provides technical leadership and oversight of viral vector manufacturing processes from pivotal to post-approval stages as well as for future second generation viral vector processes and non-viral gene delivery platforms.

The CTTO - Vector team is focused on tech transfer of vector manufacturing processes to internal and external manufacturing sites, technical oversight of the CMOs (Contract Manufacturing Operations) producing vectors used in the CAR T process, and life cycle management including process improvements. The team will be a strong partner to the GDE Technical Development team specifically with respect to tech transfers to external or internal manufacturing sites, process characterization, process control system design and process validation. The leader will also oversee a GDE MS&T lab that supports manufacturing troubleshooting, validation and comparability lab-scale studies. The role will be a member of the GMS&T network leadership team and will contribute to and influence cell therapy manufacturing and network strategies, and standards for both the Vector and CAR-T drug product.

The head is expected to hire, develop and grow strong technical talent and provide effective technical and people leadership to the Vector MS&T team. The role will work closely with the GDE Process Development, Quality, External Manufacturing, Supply Chain and CMC lifecycle teams to advance our CAR-T pipeline and establish a manufacturing network. The role will be viewed as a technical thought leader internally and externally in GDE technical community. The next 18-24 month window will require this leader to provide strong focus on ensuring on-time execution of multiple technical projects that are critical supply constraint mitigation for our two approved assets, Abecma and Breyanzi. These are some of the most complex technology transfers and LCM projects that require strong cross functional collaboration in a global regulatory health authority context.

**The roles and responsibilities include, but are not limited to, the following**:

- Ensure successful execution of the short, mid and long term viral vector supply enabling projects for Abecma and Breyanzi
- Transfer the manufacturing process developed by the viral vector process development (VVPD) group to the internal/external manufacturing site. This includes definition of the commercial manufacturing control strategy and associated enabling documents/validation or supporting technical studies.
- Ensure sound process qualification, process control and comparability strategies across vector programs
- Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy of the current vector technologies and future gene editing technology
- Serve as a decision maker on key technical issues related to manufacturing process
- Ensure and drive long-term process improvement lifecycle plan and successful execution of the technical strategy across the multiple gene delivery programs
- Participate in the CMO selection process by evaluating CMO capabilities against technical requirements
- Provide technical support of the CMOs for deviation management, lot disposition, batch record reviews to ensure that technical issues stay off the critical path for reliable supply
- Participate in the appropriate internal and joint CMO governance meetings (ex, joint steering committees)
- Provide technical support for network wide technical issues that touch or impact the CMO operation
- Ensure the CMC life cycle strategies for the vector are implemented at the CMOs to maintain manufacturing process is harmonized at all the sites
- Ensure the manufacturing process at the CMOs is in a state of validation
- Implement CPV (Continuous Process Verification) at the GDE CMOs
- Ensure mitigation plans for significant technical risks at the CMOs or key raw material suppliers
- P

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