Bristol - Myers Squibb Company

At Bristol Myers Squibb we are reimagining the future of cell therapy.. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure.. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.. Extensive management experience in a cGMP testing laboratory environment, with knowledge of regulatory and compendial guidelines as related to cell-based assay requirements, aseptic processing, and biosafety of cell therapy products.. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.

director quality control

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 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. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Senior Director, Quality Control provides senior leadership of the QC Department, comprised of QC Analytical, Microbiology, and Lab Systems and Support teams. The role oversees cGMP testing ensuring product safety and leads cross-functional teams supporting technology and method transfers. The Senior Director is a key member of the Quality Leadership Team responsible for the design, implementation, and continuous improvement of all processes/systems in support of the Quality testing program at the Bothell Cell Therapy manufacturing site. In addition, the position will be responsible for executing corporate quality policies, procedures and systems necessary to ensure adherence to aseptic operations and product management in accordance with applicable Health Authority regulations. This role reports to Bothell Site Quality Head. Duties/Responsibilities <ul><li>Extensive management experience in a cGMP testing laboratory environment, with knowledge of regulatory and compendial guidelines as related to cell-based assay requirements, aseptic processing, and biosafety of cell therapy products. Proficiency with cell-based assay methodologies, and data integrity as it pertains to data generated to support product testing. Experience with flow cytometry technology required.</li><li>The incumbent is responsible for collaborative cross-functional teamwork in organizing and developing the overall Quality Control laboratory strategy and operation, with a concentrated focus on facility utilities, raw materials, in-process testing, and final drug product testing. Responsibilities include, establishing sound control systems to sustain the performance of the facility including the development of facility preventative maintenance measures. This position will be responsible for building and maintaining reliable testing that meet US/EU and other applicable regulatory requirements, as well as within standard cycle times to meet patient scheduling.</li><li>Organizes and directs cross functional relationships with manufacturing, engineering, quality control, development and regulatory. Responsible for the hiring of staff and management of contract vendors for major programs related to the QC testing laboratory. Directs the laboratory staff, sets goals for group leaders, establishes performance objectives for the department, and maintains efficient utilization of resources.</li><li>Approves major documents in support of regulatory submissions and represent the QC operations during Health Authority inspections.</li><li>Develops, implements and enforces QC testing laboratory procedures and policies consistent with global systems, company policies and regulatory requirements.</li><li>Responsible for determining laboratory best practices through collaboration with other BMS sites, corporate level functions, and industry standards.</li><li>Ensures continued professional development of staff through training and functional interactions with various operating groups throughout the supply chain. Coaches and develops team by providing an environment that encourages ongoing personal and professional development. Manages and ensures the setting of goals, training and development opportunities, providing regularly scheduled feedback throughout the year.</li><li>Serves on internal project teams to shape the direction and influence actions based on extensive knowledge of regulatory requirements, industry standards, company strategy and laboratory technical implications.</li><li>Exerts influence in the development of objectives and long-range goals of the organization.</li><li>Uses scientific expertise to provide guidance on troubleshooting, laboratory investigations and problem resolution.</li><li>Evaluates, coaches and manages personnel performance.</li><li>Monitors department budget.</li><li>Experience in building strong, reliable, and high performing teams flexible to shifting demands.</li></ul> Qualifications <ul><li>Bachelor's degree required, preferably in Microbiology, Cell Biology, or related science. Advanced degree preferred.</li><li>Minimum of 15+ years of relevant GMP work experience required.</li><li>Minimum of 8+ years of increasing management responsibility of a cell therapy or related biopharmaceutical Quality Control laboratory.</li><li>Must have a minimum of 5 years' experience with flow cytometry.</li><li>Demonstrated experience leading a commercial operations department.</li><li>Must have experience with a startup or leading organization through dramatic growth.</li></ul> The starting compensation for this job is a range from $202,000 to $254,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. If 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 Careers With 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 Protocol Physical 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 excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments 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 cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. 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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