Associate Director

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: careers.bms.com/working-with-us.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 sitesResponsibilities: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 investigationManagement and development of a global team of experienced analytical chemistsParticipate in cross-functional teams as the analytical SMECollaborate with development teams to ensure methods are robust and appropriate for a QC commercial laboratoryManage 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/qualificationReview method validation documentation to determine compliance with current ICH requirements and manage remediation of gaps as part of Periodic Method Review programSME for bridging studies between new and existing methods, method comparability studies and product comparability studies required to support CMC changesSupport BMS Global Stability department on all analytical method related matters, including technical transfer, method support and laboratory investigationsResponsible 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 changeReview 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 reasonsContributes 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 applicationsPrepare /review and serve as SME for global and departmental procedures such as Policies, SOPs, and work instructionsExecutes on department goals and performance objectives, supports personnel development and addresses performance issuesPromotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communicationInfluences and impacts others through building and maintaining strong networks that are leveraged to obtain critical information and accomplish objectivesRecognizes and assists in resolving broad based complex issues across organizational boundariesEducationBS

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 experienceExperience/KnowledgeDemonstrated ability to lead and develop peopleThorough knowledge of cGMP/GLPs in the pharmaceutical industry, as well as technical expertise as it relates to filing and pharmacopeias requirementsUnderstanding of the regulatory requirements in CMC developmentStrong technology and scientific background in the application of analytical chemistry to pharmaceutical development, manufacture, and controlOverall awareness of the pharmaceutical manufacturing and quality processes and regulatory requirements necessary for the manufacture and distribution of pharmaceutical productsDemonstrated ability to be SME for analytical trouble-shooting and problem-solvingDemonstrated ability to write and communicate effectively representing the analytical perspective with internal project teams, senior management and external partnersExperience in the authoring and reviewing technical documentsDemonstrated ability to drive performance and achieve resultsParticipation on integrated project teamsExcellent scientific, analytical, and troubleshooting skillsStrong written, verbal, and interpersonal communication skills to clearly communicate scientific objectives and project resultsDemonstrated people management and development skillIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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