Associate Director, Cell Therapy Drug Product Process Development (R1556693-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, the growth potential of the science – and its ability to help patients – is incredible.
The Associate Director (AD), Drug Product Process Development (DPPD) is responsible for process technology innovation and development strategies for autologous and allogeneic drug products. The AD will lead projects as well as have accountability for the delivery of a portfolio of projects with direct oversight of multiple program and technology teams that drive rapid development and implementation of new technologies and processes into CMC programs and ensure functional excellence for regulatory strategies for future INDs and BLAs. The AD will contribute long-term technology and operational strategies, which requires strong technical partnership and collaboration with multiple stakeholders including Manufacturing, CMC, Analytical Development, Quality, Regulatory, Research, and Early Development.
- Develop and execute process development and strategies for clinical and commercial manufacturing of engineered Cell Therapy products.
- Leading a team to develop high-performing cell therapy processes for both early and late-stage programs
- Participating in cross-functional CMC Development Teams providing process development input from FIH through pivotal development and product commercialization.
- Responsible for authoring and input for CMC sections of the IND/BLA. Supporting regulatory submissions, regulatory interactions, writing/reviewing regulatory responses, and pre-approval inspections.
- Collaborating with internal Clinical manufacturing team as well as external CMOs for tech transfer and process scale-up including performing risk assessment and developing appropriate mitigation strategies.
- Working with the leadership team on resource planning including CAPEX/OPEX as well as workforce arrangement based on program priority.
- Supporting new technology assessment including external collaborations for improved process understanding. Developing appropriate IP strategies to ensure FTO and to create and strengthen our patent estate in the field.
- Writing technical summary and development reports for efficient knowledge management and regulatory filing support.
- Contribute to cell and gene therapy insights and technology through publications and external partnerships to deliver best-in-class therapies to patients.
- Leading strategies around off-the-shelf products such as iPSC-based buildout initiatives in collaboration with external partners and allogeneic programs as needed.
Qualifications and Experience:
- Minimum of 6 years of experience in pharmaceutical development with a Ph.D. in a technical discipline (e.g., biology, biotechnology, biochemistry, pharmacy) with demonstrated excellence in cell therapy development (10 years with BS/MS).
- Knowledge and direct experience in developing cell therapy processes and technologies. Experience with regulatory filings of immunotherapy products is preferred.
- Demonstrated excellence in developing, mentoring, and managing staff.
- Proven leadership and ability to positively influence colleagues and key decision-makers.
- Expertise in iPSC differentiation and iPSC scale-up or equivalent is highly desirable.
- Demonstrated collaboration skills working cross-functionally, maintaining strong stakeholder relationships, influencing direction, voicing an opinion, and communicating effectively.
- Demonstrated business acumen with the ability to draw insights from data quickly, perform analysis, and present business cases.
If you want to advance 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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