Executive Director/Vice President, Cell Therapy Process Development (R1555538-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
Cell Therapy Process Development organization develops manufacturing processes to enable current and new product formats, increased product control, lower cost, and lower operational complexity. The head of this organization is accountable for global network of CT process development, overseeing teams located in Seattle, WA and Warren, New Jersey. This organization drives innovation and implementation of end-to-end practices for cell therapy drug product processes, from FIH processes to commercial ready processes, including the overall technology strategy for CT processes. The leader will be responsible for a holistic CT DP process development strategy to ensure enterprise level considerations are applied across the portfolio of CT assets including all autologous, allogeneic and iPSC/NK based approaches, influencing overall CT development strategy. This role will sit on the Cell Therapy Technical Development leadership team and will drive enterprise collaboration with relevant areas across research, commercial operations, and CT strategy.
- Lead all CT DP process development activities and teams across Seattle, Warren sites, a team of >100 staff
- Develop and implement cost effective and cost competitive processes for all cell therapy approaches,
- Develop phase appropriate processes to enable speed on portfolio delivery
- Define and harmonize global strategies for developing, characterizing and enabling validation of CT drug product processes for both early and late stage assets as applicable
- Develop and lead global strategy and implementation of DP process strategy aligned with the internal operations network, the research strategy and commercial considerations for CT
- Provide technical input on CT process related investigations at internal and external manufacturing sites as required.
- In partnership with manufacturing, drive novel technologies, expression platforms, and associated IP helping to protect and create value for the BMS portfolio of CT assets
- Responsible for developing and implementation of PAT as it relates to CT DP processes in the network
- Partner and collaborate with other functions at BMS, and leverage expertise in the broader BMS development functions as required
- Support business development activities; drive engagement with the broader external CT community and influence direction of the field
- Contribute to, review and approve regulatory CMC submissions to ensure their quality and technical content
- Build high performing teams that excel at working in matrices across BMS. Attract, hire, manage and develop world class scientific, technical and engineering talent and create an environment where they thrive.
- Create strong partnerships to continually evaluate and evolve the department’s strategic plan to ensure alignment with business objectives while balancing cost, time and speed.
- Serve as a member of the CT Development leadership team, participating in portfolio review and project governance meetings and providing guidance for best practices and direction for continuous improvement.
- Reports to Vice President of Cell Therapy Technical Development
Essential Skills and Experience
- PhD preferred in biochemistry, biochemical engineering, chemical engineering or other related fields
- Minimum of 15 years experience leading teams of people (leading leaders) across multiple geographic locations (~25 % travel required)
- Demonstrated experience in developing and establishing process strategies required for early, late, and commercial stage biologics/ Cell therapy processes
- Experience with integration of process control strategies with understanding of attribute sciences; Experience with process characterization of large molecule processes
- Broad understanding of CT and/or biologics processes and production technology
- Experience with multiple analytical techniques used to characterize and quantify biologics/CT approaches
- Ability to work across all CT approaches (autologous, allogeneic, gene-edited, iPSCs etc)
- Experience partnering with CMC teams to define and deliver technology strategy required for product licensure.
- Experience with partnering externally on product development
- Strong organizational skills, ability to multitask and work in a dynamic, fast paced environment.
- Strong people development experience; expertise in driving change and managing large organizations
- Demonstrated people development experience in a global setting; proven experience and expertise in driving change and building organizations with an enterprise mindset
- Ability to collaborate cross-functionally across multiple matrix partners/teams
- Ability to communicate and operate as a thought leader in the CT/process development space
- Strong external network and influence in the field
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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