Senior 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 Senior Director will be accountable of leading the gene delivery analytical development group within the Gene Delivery Process and Analytical Development (GDPAD) organization supporting clinical and commercial cellular products. This group develops release and characterization methods for our gene delivery materials, which include lentiviral vectors (LVV), adeno-associated viral vectors (AAV) and non-viral based gene delivery materials. In addition to method development and qualification, the group supports method transfers to Quality Control labs and is responsible for the determination of our critical quality attributes (CQAs) for gene delivery materials.. This analytical organization is accountable for operations involving the execution of the viral vector determination testing procedure for disposition of a commercial lentiviral vector. In this capacity the Senior Director will oversee a large team with responsibility for GMP testing to support product release and stability, non-GMP testing to support process development, and various life cycle management initiatives, including a lab capacity expansion project that is required to support the increased commercial demand of the product. The Senior Director will also 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 and analytical methods. 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 analytical development expertise in biotechnology or cell and gene therapy areas, regulatory and compliance awareness, strategic thinking, strong business acumen, excellent leadership and influencing skills.
Supervise technical leaders and people managers of the Vector Release Methods group; hire, mentor and develop exceptional team members; cultivate diverse and complimentary analytical skill sets within the group
Oversee GMP testing operations for vector volume determination test for a commercial lentiviral vector
Support method development, qualification and transfer to Quality Control labs
Provide technical leadership on gene delivery analytical topics within group
Ownership of overall gene delivery analytical platform
Represent gene delivery analytical development cross-functionally to members of Process Development, Global Product Quality, and Cellular Process and Analytical Development
Communicate and coordinate with the Gene Delivery Analytical Strategy team to support program deliverables
Represent gene delivery analytics at various BMS governance forums
Ensure appropriate technical representation from program activities including author sections of regulatory submissions and requests for information, technical investigations, and business development opportunities
Accountable for documentation practices within the team including analytical target profiles, method qualification/technical/method bridging reports, and VVDT quality systems work product
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.
B.A./B.S. with ≥ 18 years of experience or Ph.D. with ≥ 10 years of experience in biotechnology or cell and gene therapy with exposure to all stages of product development
Broad experience in analytical development including method development, qualification and reviewing relevant regulatory submissions; knowledge of molecular, biochemical (ELISA), and high-complexity cell based analytical methods
Highly developed interpersonal, communication and negotiation skills, including the ability to clearly articulate complex options to senior decision makers.
Experience collaborating with external contract test labs; understanding risks and typical pitfalls of an external network
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 gene delivery analytical and VVDT teams towards their 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.
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