Manager, QC Analytical Testing

**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: /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 Manager, QC Analytical Testing is responsible for all operational aspects of the QC Analytical Testing department at the Cell Therapy Operations (CTO) manufacturing facility during clinical and commercial phases. This department is responsible for Flow Cytometry and Molecular Biology based testing of in-process samples, final drug product testing, stability testing, validation and requalification support, critical reagent testing and qualification, training, deviation, CAPA, and change controls and other critical support as needed. The Manager, QC Analytical is responsible for continuously maintaining the GMP status of the QC Laboratory, applying and ensuring staff complies to EHS rules and safe work practices per applicable procedures, while still performing hands-on testing as needed. **Shift Available:** + Wednesday - Saturday, Onsite Day Shift, 8 a.m. - 6 p.m. **Responsibilities:** + Manages all activities related to the QC Analytical Testing department including: + GMP release of in-process and drug product testing results. + Documentation of GMP release activities. + Ensures the laboratory is inspection ready at all times. + Perform data review of experiments, governing procedures, protocols and release data. + Participate in complex projects and continuous improvement efforts. + Perform and document training effectively. + Method development and validation. + Manages and develops direct reports including: + Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs. + Ensuring employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports. **Knowledge & Skills:** + Extensive experience with flow cytometry and cell imaging, including flow related technologies related to analysis. + Extensive experience with various molecular biology analytical techniques including but not limited to ELISA, qPCR, and scientific knowledge in the characterization and transfer of pharmaceutical products. + Knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products. + Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences + Ability to collaborate cross functionally to drive operational and quality excellence. + Advanced organizational and time management skills. + Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills with only general guidance. + Advanced teamwork and facilitation skills. + Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills. + Requires strategic thinking and ability to work independently. + Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments. + Ability to interpret and author general, technical, and complex business documents. + Advanced knowledge and implementation of data integrity principles. + Ability to represent the department in regulatory inspections. + Communicate effectively with management regarding task completion, roadblocks, and needs. + Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance. + Proficiency in MS Office applications **Basic Requirements:** + Bachelors' degree required, preferably in Biology, or related science. Advanced degree preferred. An equivalent combination of higher education and experience may be considered. + 3 years of relevant work experience in QC Analytical testing within a manufacturing GMP facility. + Minimum of 1 year flow cytometry experience. + People leadership: A minimum of 1 year with a bachelor's degree or 0 years with a master's degrees. **Working Conditions:** + The incumbent will be required to work in office and laboratory environments. + The incumbent may be required to gown for entry into the Aseptic Core and other supporting areas on an as-needed basis. + The incumbent (or designee) will be expected to be on call to support manufacturing issues involving sampling and/or test excursions or questions during shift operations. + Occasional travel may be required. BMSCART, #LI-Onsite 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** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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 . Visit / ( 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. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R **Updated:** :33:58.920 UTC **Location:** Summit West-NJ Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Created: 2024-11-05