Manager, Night Shift Cell Therapy Quality Control (R1551105-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol Myers Squibb is seeking a Manager, Night Shift Cell Therapy Quality Control for our Devens, MA. This role will manage the operations of the QC Sample Management shift, responsible for the management of QC samples and materials in support of the QC laboratories. This includes, but is not limited to, mentoring, training and managing the QC Sample Management team, maintaining and tracking testing samples, retains, scheduling lab operations, supporting lot release, creating and continuously improving processes, reviewing and approving documents, and overseeing sample tracking, delivery, and destruction.
This role works from 6PM to 6AM following a 12-hour rotating shift (36/48 hours over a 2-week period) which includes working every other weekend, holidays falling on scheduled workdays, and during adverse weather conditions in support of QC and the manufacturing facility. Flexibility to work irregular hours and short notice overtime may be required.
This role is stationed in Devens, MA and reports to the Senior Manager of QC Sample Management and Planning.
Provide supervision of QC Sample Management shift and oversee the daily Sample Management activities related to in-process, final release and stability testing of cell therapy drug product.
Develop and manage a daily work plan for QC associates. Report out quality and operational metrics.
Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures. Facilitate cold chain transfers of samples, as required.
Hire, mentor and develop the team members to support the business operations and employee career development.
Oversee the training of the team members.
Review and approve procedures for Sample Management activities.
Collaborate with other departments to identify and implement process improvements.
Own and evaluate relevant change controls, investigations, deviations, CAPAs.
Apply critical thinking skills when working on new procedures or process improvements.
Communicate effectively with management regarding task completion, roadblocks, and needs.
Perform other tasks as assigned.
Bachelor’s degree required, preferably in Chemistry, Microbiology or related science.
6+ years of relevant work experience, preferable 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.
The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.
Experience with cold chain sample storage and transfer in a GMP regulated environment.
Familiar with Excel, Visio, Power Point, and other software systems.
Experience with laboratory LIMS 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 assignment while meeting timelines in a GMP environment.
Advanced ability to work in a collaborative team environment and train others.
Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
Excellent organizational and critical thinking skills.
Advanced ability to communicate effectively with peers, department management and cross-functional peers.
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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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