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Manager, QC Microbiology, Cell Therapy

1 month ago


Devens, United States Bristol-Myers Squibb Full time

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.Job SummaryBristol Myers Squibb is seeking a Manager for QC Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. This role will manage the daily operations of the QC Microbiology shift, responsible for environmental/utility monitoring and QC microbiology testing and data review for in-process and release testing of clinical and commercial cell therapy drug product. The Manager, QC Microbiology will also be responsible for hiring, mentoring, and developing the QC Microbiology teamto support business operations and employee career development. Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions. This position directly leads the QC Microbiology shift scheduled for Wednesday to Saturday 6AM – 4PM.This role is stationed in Devens, MA and reports to the Senior Manager, QC Microbiology.Job ResponsibilitiesSupervise the QC Microbiology lab staff on shift and oversee the daily lab activities related to environmental/utility monitoring, in-process, and final release testing of cell therapy drug product.Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved.Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities.Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements.Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures.Own and evaluate relevant change controls, investigations, deviations, CAPAs.Hire, mentor, and develop team members to support the business operations and employee career development.Oversee training of the team members.Communicate effectively with management regarding task completion, roadblocks, and needs.Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings.Perform other tasks as assigned.Qualifications and Education RequirementsExperience with microbiology assays and associated equipment.Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred.Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment.Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.Excellent organizational and critical thinking skills.Advanced problem-solving ability/mentality, technically adept and logical.Advanced ability to communicate effectively with peers, department management and cross-functional peers.Proficient with Excel, Visio, PowerPoint, and other common software applications.Bachelor’s degree required, preferably in Microbiology or related science.6+ years of relevant laboratory work experience, preferably in a regulated environment.2+ years of management and people leader experience.An equivalent combination of education and experience may substitute.The incumbent will be working around biohazardous materials.If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.BMS CAR-TIf 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 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.