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.
The Associate Director will be responsible for leading a team of both direct and matrix reports responsible for delivery of drug substance and drug product analytical control strategies including methods, specifications, and comparability studies. In addition the associate director will contribute directly and through the team to prepare global licensure applications, define strategy for follow-up measures, and prior approval submissions as well as author/review associated regulatory filings.
Through strong leadership, the Associate Director will ensure the support of analytical methods and analytical change control across the BMS network, for third party manufacturing and partners at external testing labs. Duties/Responsibilities:
- Create and maintain effective partnerships with stakeholders from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.
- Accountability for strategy and execution of analytical activities required to advance late-stage programs and manage the lifecycle of commercial programs.
- Leads a team responsible for delivery of analytical CMC strategy; provide
- Supervises colleagues responsible for various aspects of analytical CMC strategy definition and/or execution. Ensures appropriate impact and output of all colleagues through effective performance management and career development
- Leads effective matrix analytical support during all BLAs, ROW & PAS filing review and works with analytical development in supporting the responses to FUMs and PMCs.
- Co-leads the effort to implement effective control strategy, analytical method and specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs.
- Coordinates optimization and improvement of analytical program support.
- Serves as project expert during inspections
- Contributes to strategy and operations across the Analytical Sciences and Technology organization
Education and Experience
- A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 10, 13 or 15 years of industrial experiences in relevant fields, respectively.
- Demonstrates a broad expertise and knowledge in analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product. Experience in product characterization and strategies to establish process and product knowledge.
- Comprehensive knowledge of biologics CMC regulations and working knowledge of cGMP requirements
- Experience authoring/reviewing regulatory submissions
- Demonstrated leadership capability (via direct supervision or leadership of matrix teams).
- Strong communication and leadership skills in a highly interactive environment.
- Demonstrated skills in leading cross-functional strategic teams and collaboration with internal and external partners..
- Strong decision making skills
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.