Associate Director, Gene Delivery Process and Analytical Development
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.
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.
The Associate Director will be accountable of leading a viral vector process development group within the Gene Delivery Process and Analytical Development (GDPAD) organization supporting clinical and commercial cellular products. The Associate Director will be accountable to establish the joint viral vector lab which will be shared between viral vector process development and vector manufacturing sciences and technology (MSAT). This Associate Director will lead a small group accountable for assisting in technology transfer of vector processes into vector manufacturing, implementation of new technologies into vector manufacturing, performing lab work to support closure of manufacturing deviations, and establishing scale-down models for our vector processes. Additionally, this Associate Director will be accountable for our gene delivery process characterization strategy and to build out a viral vector process characterization center of excellence. This Associate Director will be part of the GDPAD leadership team and play a critical role in establishing our high-level strategies and platforms for viral vector and gene editing raw material processes. This is a highly visible and influential role in the organization that will interact extensively with partner organizations, senior leadership across BMS, and external collaborators. To be successful in this role, the ideal candidate must have extensive product development expertise in biotechnology or cell and gene therapy areas, regulatory and compliance awareness, strategic thinking, strong business acumen, excellent leadership and influencing skills.
• Establish and lead a small viral vector process development team in New Jersey
• Support tech transfer into vector manufacturing
• Lead all CMC activities, including process characterization and tech transfer for pivotal production, required for successful, on-time global regulatory filings
• Establish our viral vector process characterization strategies and build out a team capable of supporting the viral vector process characterization work required by the cell therapy franchise
• Define viral vector CMC goals, milestones, and timelines for the team, coordinate and monitor progress, and manage team activities to ensure successful implementation of the endorsed development plan
• Represent the viral vector CMC team in CMC technical and program reviews with governance boards and senior management
• Provide regular communications to the team, sub-teams, functional lines, stakeholders, and management. Escalate issues and risks, and recommend risk mitigation strategies according to governance procedures.
• Stay abreast of evolving global regulations and industry practices for the development and approval of Cell Therapy products worldwide.
• Create a high functioning team, holding team members accountable for performance, and mentoring/coaching as needed. Provide input into the performance reviews of team members.
• Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies.
• B.A./B.S. with ≥ 14 years of experience or Ph.D. with ≥ 8 years of experience in biotechnology or cell and gene therapy with exposure to all stages of product development
• Experience on CMC teams including authoring and reviewing relevant regulatory submissions
• Highly developed interpersonal, communication and negotiation skills, including the ability to clearly articulate complex options to senior decision makers.
• Experience collaborating with external manufacturing organizations; understanding risks and typical pitfalls of external manufacturing
• Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a cross-functional matrix environment.
• Proven ability to work effectively with cross-functional leaders in a complex/changing global environment.
• Subject-matter expertise to strategically lead the CMC team towards its goals
• Demonstrated experience in preparing and executing complex strategic plans and balancing competing priorities.
• Strong problem-solving and risk-based decision-making skills and a strong ability to influence or manage without direct authority.
• Demonstrated ability for critical and strategic thinking
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.