Executive Director, Cell Therapy Technical Operations - Summit, United States - BioSpace

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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.

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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
• Establish the requirements for the commercial manufacturing process for future viral and non-viral vector platform and ensure application of these requirements throughout the product life cycle.
• 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
• 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 MS&T 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

• Executive Director level: BS, MS, PhD in Chemical Engineering, or life with years of direct experience in GMP environment in Biotech industry, 7+ years of people management, 5 plus years of experience in cell culture process development or manufacturing. Candidates with the lower end of experience range may be considered at Senor Director level.
• 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, MS&T and external manufacturing.

The starting compensation for this job is a range from $245,000 USD - $325,000 USD, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

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