Job Description

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 Responsibilities

* Create/revise SOPs for Sample Management activities.
* Managing QC samples, laboratory reference standards, assay controls, and critical materials including chain of custody, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures. Facilitate cold chain transfers of samples, as required.
* Maintain the reference standard, critical reagent inventory and distributing to functional groups upon request.
* 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, oversee the training of the team members.
* Create, revise and review technical documents, such as SOPs and working instructions for sample and critical reagent management.
* Collaborate with other departments to identify and implement process improvements.
* Owning and evaluating 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

* Experience with cold chain sample storage and transfer in a GMP regulated environment.
* Ability to work in a classified cleanroom environment and follow all applicable gowning requirements and procedures.
* Proficient in the use of LIMS or other sample tracking software and familiar with SAP, Excel, Visio, Power Point, and other software systems.
* Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.
* Ability to write and revise SOPs and working instructions.
* 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.
* 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.
* Bachelors degree required, preferably in Chemistry, Microbiology or related science.
* 4+ years of relevant work experience, preferable in a regulated environment.
* An equivalent combination of education and experience may substitute.
* The incumbent will work 40-hours per week. Support manufacturing operations that may include shift coverage consisting of on call, shift, and/or weekend coverage.
* The incumbent should be able to distinguish colors and possess correctable vision to 20/20.
* The incumbent will be doing light to moderate lifting and carrying objects under 15-20 lbs.
* The incumbent will be working around biohazardous materials.
* The incumbent 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, theres 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 CART

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.

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.