Director or Senior Director Vector and Gene Delivery Manufacturing Sciences and Technology

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Come and join the BMS Cell Therapy Development and Operations (CTDO) Division and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. Our cell therapy platforms are based on two distinct and complementary technologies – Chimeric Antigen Receptors (CARs) and T-Cell Receptors (TCRs). Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

The Global Manufacturing Science and Technology (GMSAT) Division of CDTO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network. As the Director of Vector/Gene Delivery MSAT you will report to the Vice President of GMSAT. 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 process engineers that is currently staffed with 9 members and expected to grow to 12 - 15 over the next two years. The Vector MSAT team provides technical leadership and oversight of viral vector manufacturing processes from pivotal to post-approval stages. The team, led by this role, 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 vector life cycle management including process improvements. The team also supports pre-pivotal technical development activities specifically with respect to tech transfers to external or internal manufacturing sites.

The leader will also oversee a Vector MSAT lab that supports manufacturing troubleshooting, validation and comparability lab-scale studies. The role will be a member of the GMSAT 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 MSAT team. The role will work closely with the Viral Vector 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 viral vector manufacturing

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


Establish the requirements for the commercial manufacturing process for viral vector (or future gene delivery platforms) and ensure application of these requirements throughout the product life cycle.

Transfer the manufacturing process developed by the viral vector development 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 issues related to manufacturing process (especially those with implications to the broader portfolio)

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 CMOs

Ensure mitigation plans for significant technical risks at the CMOs or key raw material suppliers

Provide technical leadership/support to regulatory/health authority questions for the CMO manufacturing operation (either part of the initial licensure or post approval changes or routine inspections)

Review, approve validation plans, protocols as appropriate

Review, approve sections of the regulatory dossier, briefing books or communications to health authorities

Ensure that MSAT role in the CMO virtual plant teams is aligned across CMOs to ensure proper calibration of CMO oversight practices

Develop risk-based strategies for the CMO technical oversight taking into account the product life cycle, technical complexity and CMO capabilities.

Interface with the CMC and TCT teams to support planned LCM projects as well as unplanned requests to support the product globally.


Basic Qualifications: Position will be filled at a level commensurate with experience.

Director level:

Bachelor's degree in a Life Sciences or Chemical Engineering discipline and a minimum of 12 years of relevant biotechnology or pharmaceutical industry (operations, technical development, MSAT)

Senior Director level:

Bachelor's degree in a Life Sciences or Chemical Engineering discipline and a minimum of 15 years of relevant biotechnology or pharmaceutical industry (operations, technical development, MSAT), with a strong preference for previous gene and cell therapy experience.

Other requirements:


10 years of direct experience in GMP environment, 7 plus years of people management, 5 plus years of experience in cell culture process development or manufacturing





Previous experience leading global teams in multiple locations

Previous experience in technical oversight of CMOs and suppliers

Demonstrated ability to hire, coach and grow technical talent

Experience in product/process CMC life cycle management including launch and post- approval

Strong analytical, problem-solving, and critical thinking skills

Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent

Excellent written and verbal communication skills at all levels in the organization


Preferred Qualifications


2-3 years of experience in cell therapy process development and or manufacturing.

Combination of experience in process development, MSAT and external manufacturing.


Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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