Senior Specialist, QC Sample Management, Cell Therapy

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.

Job Summary

Bristol Myers Squibb is seeking a Senior Specialist for QC Sample Management (QCSM) at the Cell Therapy Facility (CTF) in Devens, MA. The Senior Specialist is responsible for providing support to QC Sample Management shift operations and planning. This includes but is not limited to, serve as QCSM Subject Matter Expert to support operator training, deviation investigations, CAPAs, laboratory process improvements, also serve as backup planner to support whole QC department operational scheduling. This position is a 40-hour work week role but may occasionally require interface with day (6am-6pm) and night (6pm-6am) shifts to support investigations and non-routine projects.

The QCSM Senior Specialist role is stationed in Devens, MA and reports to the Senior Manager, QC Sample Management and Planning.

Job Responsibilities

• Support QCSM shift operations and planning. Manage QC samples including chain of custody, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures. Facilitate cold chain transfers of samples, as required.

• Ensure samples and materials are appropriately labelled and traceable according to GMPs, regulatory requirements, and written procedures.

• Serve as trainer of the QC Sample Management team, documenting training per procedural and cGMP requirements.

• Create, revise and review technical documents, such as SOPs and working instructions for sample management.

• Collaborate with other departments to identify and implement process improvements.

• Own and evaluate relevant change controls, investigations, deviations, CAPAs.

• Implement 5S and FIFO principles as appropriate.

• Apply critical thinking skills when working on new procedures or process improvements.

• Communicate effectively with management regarding task completion, roadblocks, and needs.

• Performs other tasks as assigned.

Qualifications and Education Requirements

• Bachelor’s degree, preferably in Chemistry, Microbiology or related science.

• 4+ years of relevant work experience, preferably in a regulated environment. An equivalent combination of education and experience may substitute.

• Experience with sample storage and transfer in a GMP regulated environment.

• Experience in LIMS or other sample tracking software and familiar with Excel, Visio, Power Point, and other software systems.

• Experience in writing and revising GMP procedures and working instructions.

• Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment.

• 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.

• The incumbent will be working around biohazardous materials and may be exposed to fluctuating and/or extreme temperatures on occasion.

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.

BMSCART

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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