Associate Director

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 - Global Quality Analytical Science and Technology / Method Lifecycle is responsible for managing a global team of analytical chemists that provides lifecycle management of the commercial testing methods supporting the BMS pharma (small molecule) portfolio. The incumbent provides expertise and guidance to problem-solving efforts at BMS and third-party manufacturing and testing sites, including laboratory investigations and troubleshooting QC & operational issues. The team performs analytical method remediation, validations/verifications, implementation, and transfer of analytical procedures according to the BMS Quality System. Additional aspects of lifecycle management include, (1) working with MST on continuous improvement initiatives; (2) working with CMC for ROW expansion and ensuring Regulatory expectations are met and up to date; and (3) participating in monitoring method performance by tracking strategic parameters throughout the lifecycle of the method. The Associate Director will provide critical input to technical documents and regulatory filings/responses. In collaboration, with development teams, the method lifecycle team ensures methods are fit for purpose in commercial QC environment and participates in new product introductions at commercialization sites Responsibilities: The Associate Director is the SME for executing the overall scientific, technical, and operational efforts of pharmaceutical method lifecycle group. Group responsibilities include delivery of analytical methods needed to meet project milestones and product launches throughout the world, as well as associated regulatory and international requirements. The Associate Director and group provides SME leadership to BMS and external QC labs with method troubleshooting and laboratory investigation Management and development of a global team of experienced analytical chemists Participate in cross-functional teams as the analytical SME Collaborate with development teams to ensure methods are robust and appropriate for a QC commercial laboratory Manage and oversee the technical transfer of analytical methods to BMS and external testing labs, including new product introductions at commercialization sites. Review and approve technical documents (e.g., protocols and reports) Review and approve protocols and reports for analytical method validation/qualification Review method validation documentation to determine compliance with current ICH requirements and manage remediation of gaps as part of Periodic Method Review program SME for bridging studies between new and existing methods, method comparability studies and product comparability studies required to support CMC changes Support BMS Global Stability department on all analytical method related matters, including technical transfer, method support and laboratory investigations Responsible for analytical method change controls within the company Quality Management System and to ensure all required test data and reports are available to support and justify the change Review of change controls for impact to analytical methods and method validation status based on changes to manufacturing process or materials, compendial monographs/ chapters. Specification changes and other reasons Contributes and reviews technical documents and CMC analytical sections of regulatory submissions; prepare and review responses to questions raised by Health Authorities; ensures delivery of high-quality CMC sections in regulatory filings; addresses CMC-related inquiries from regulatory agencies to support commercial marketing applications Prepare /review and serve as SME for global and departmental procedures such as Policies, SOPs, and work instructions Executes on department goals and performance objectives, supports personnel development and addresses performance issues Promotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication Influences and impacts others through building and maintaining strong networks that are leveraged to obtain critical information and accomplish objectives Recognizes and assists in resolving broad based complex issues across organizational boundaries Education BS in science with at least 15 years; or MS in science with at least 14 years; or Ph.D. with at least 12 years of relevant pharmaceutical experience Experience/Knowledge Demonstrated ability to lead and develop people Thorough knowledge of cGMP/GLPs in the pharmaceutical industry, as well as technical expertise as it relates to filing and pharmacopeias requirements Understanding of the regulatory requirements in CMC development Strong technology and scientific background in the application of analytical chemistry to pharmaceutical development, manufacture, and control Overall awareness of the pharmaceutical manufacturing and quality processes and regulatory requirements necessary for the manufacture and distribution of pharmaceutical products Demonstrated ability to be SME for analytical trouble-shooting and problem-solving Demonstrated ability to write and communicate effectively representing the analytical perspective with internal project teams, senior management and external partners Experience in the authoring and reviewing technical documents Demonstrated ability to drive performance and achieve results Participation on integrated project teams Skills/Competencies Excellent scientific, analytical, and troubleshooting skills Strong written, verbal, and interpersonal communication skills to clearly communicate scientific objectives and project results Demonstrated people management and development skill 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.