Associate Director, Campus Laboratory and Benchtop Systems

Job description

Working with Us Challenging. 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. 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 Devens Campus Laboratory and Benchtop Systems Associate Director serves as the campus-wide lead for all laboratory informatics and benchtop instrument systems, providing strategic leadership and accountability for the deployment, validation, integration, and lifecycle management of laboratory technologies supporting GxP and non-GxP research and quality operations across the site. This position is responsible for defining requirements, driving continuous improvement, and maintaining the validated state of laboratory systems, while working collaboratively with Quality, Research, Manufacturing, Engineering, enterprise teams, and other BMS network sites. The role ensures that all laboratory systems comply with BMS regulatory, data integrity, and cybersecurity expectations. Additionally, the Associate Director leads and empowers the campus Laboratory and Benchtop Systems team, including overseeing instrument qualification and laboratory informatics activities, and partnering with enterprise platform teams to support site laboratory priorities. Duties/Responsibilities Lead the Campus Laboratory and Benchtop Systems team Promote a safe and compliant environment and mindset. Select, develop, coach, and manage the Devens Campus Laboratory and Benchtop Systems team. Set goals, objectives, and contributions of the Campus Laboratory and Benchtop Systems team. Drive continuous improvement of team productivity and KPIs. Ensure the team delivers critical projects on time. Act as a liaison between laboratory and research stakeholders and enterprise/application teams to ensure laboratory system continuity and alignment with scientific needs. Manage service providers and ensure alignment with contractual SLAs. Engage and support PBRG teams in support of the BMS culture. Act as the campus-wide process owner for laboratory systems qualification, validation, and lifecycle management Provide guidance to laboratory scientists, Quality, and site functional groups on instrument qualification (IQ/OQ/PQ) and laboratory informatics system validation processes. Participate actively with other groups to analyze and address process deficiencies. Support the BMS Data Integrity and Quality Risk Management programs. Lead campus-wide laboratory and benchtop systems support and project execution Ensure appropriate support for laboratory and GxP operations across the Devens campus, including LIMS, ELN, CDS, SDMS, and benchtop instrument connectivity. Define, implement, and track Service Level Agreements (SLA) for supported business-critical activities. Collaborate with Devens laboratory operations and Digital Plant leaders to address issues and develop plans to enhance laboratory system reliability and user experience across the site. Manage organizational adoption of BMS standard laboratory systems and processes, including LIMS, ELN, and chromatography data systems, and continuously enhance processes to simplify laboratory workflows. Foster business and enterprise partner relationships to ensure a high customer satisfaction rating. Represent laboratory systems during internal audits and regulatory inspections, serving as the subject matter expert for laboratory informatics and instrument qualification. Ensure that procedures, guidance documents, and other GxP-related documents are maintained in a high state of compliance and audit readiness. Ensure the qualification, validation, implementation, and change management of laboratory and benchtop systems used across the site are conducted in compliance with applicable regulatory requirements, including USP, EP, and ICH guidelines. Participate actively with other groups to analyze and address process deficiencies, working collaboratively with peers in Laboratory Sciences, Validation, Manufacturing, Quality, and Digital Plant. Effectively track project progress to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies. Provide updates to management through established tools and project dashboards. Pursue innovative solutions. Periodically review, specify, and revise laboratory informatics systems and benchtop instrument integrations supporting site scientific and quality operations. Follow industry trends and innovation, finding new technical solutions to meet evolving business needs Evaluate vendor recommendations and lessons learned from other BMS sites. Qualifications · Ability to lead highly effective teams both at a local site level and across the network. · Strong collaboration and cross-functional leadership skills to drive continuous improvement, promote knowledge sharing, and implement best practices across the network. · Communicates effectively across different levels of the business. · Ensures accountability and takes responsibility to drive successful outcomes on key initiatives. · Works both independently and in a team environment at all levels of the organization, particularly across Laboratory Sciences, Validation, Quality, Engineering, and Digital Plant. · Exercises sound judgment in making decisions and recommendations within generally defined practices and policies and notifies senior management when necessary. · Ability to work in a diverse work environment and manage multiple priorities. · High degree of familiarity with health authority requirements pertaining to laboratory systems and data, including Data Integrity, 21 CFR Part 11, USP Analytical Instrument Qualification, and GAMP 5 guidance for laboratory computerized systems. · Strong attention to safety is a must. · Bachelor’s degree in Life Sciences, Chemistry, Engineering, Information Technology, or related field, with a minimum of 12 years of experience in pharmaceutical laboratory operations, laboratory informatics, instrument qualification, analytical systems, and/or IT roles supporting laboratory environments. · Proven leadership skills and track record of success in managing laboratory informatics programs, instrument qualification initiatives, and benchtop systems across a multi-functional campus. · Demonstrated leadership skills in coaching, managing, and mentoring staff members, including effective team selection and personnel management. · Expertise in 21 CFR Part 11, USP , GAMP 5 Category 3/4/5 systems, and ICH Q2/Q7 guidelines; hands-on experience with LIMS (e.g., LabWare, SampleManager), ELN, CDS (e.g., Empower, Chromeleon), and SDMS platforms is required. · Knowledge of Quality principles, system development lifecycles, and QA methodologies, such as ISO 9001. · Experience with IT oversight and integration of laboratory instruments and electronic systems supporting GMP and R&D operations is required, including familiarity with instrument connectivity, data acquisition, and benchtop automation. · Demonstrated ability to work effectively with US FDA and other regulatory agencies. · Substantial knowledge of QSR, GMP, FDA, GAMP, ISO, ICH, and other applicable standards