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 Summary

Bristol Myers Squibb is seeking a Scientist for Flow Cytometry at the Cell Therapy Facility (CTF) in Devens, MA. The QC Scientist is responsible for supporting Quality Control bioanalytical testing for the release of clinical and commercial products for QC Flow Cytometry Department. This department is responsible for Flow Cytometry based testing of in-process samples, final drug product testing, stability testing, Validation and requalification support, critical reagent testing and qualification, training and other critical support as needed. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.

The Senior Specialist role is stationed in Devens, MA and reports to the Associate Director of Flow Cytometry for the Devens CTF.

Job Responsibilities

* Perform testing of the in-process, final product, and stability samples.
* Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
* Capable of handling complex issues and solving problems with only general guidance.
* Prepare and present continuous improvement projects to management.
* Comprehensive understanding of regulatory guidelines and can independently, develop, write and execute methods, protocols, reports and other related documents.
* Review all data in accordance with applicable procedures and cGMP requirements.
* Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
* Train new analysts to general job duties.
* Complete necessary training to become a qualified trainer.
* Perform training effectively.
* Document training per procedural and cGMP requirements.
* Support document revision, project, CAPA, and investigation/deviation tasks.
* Perform assigned tasks within a CAPA, deviation, or project
* Participate in complex projects and continuous improvement efforts.
* Take a leadership role, as required, for projects.
* Draft and review technical documents, such as SOPs and protocols/reports.
* Communicate effectively with management regarding task completion, roadblocks, and needs.
* Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.

Qualifications and Education Requirements

* 3-5 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
* Demonstrated experience working with polychromatic flow cytometry panels and flow cytometry data analysis.
* 3+ years of experience in multi-parameter (>8-color) flow cytometry execution, training, and technical support. Experience in cellular therapies is preferred.
* Strong technical background and expertise with multiple flow cytometry platforms preferred, including BD Biosciences platforms.
* FCS Express software experience is a plus.
* Advanced hands-on experience with various analytical techniques primarily flow cytometry and scientific knowledge in the characterization and transfer of pharmaceutical products.
* Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
* Advanced technical writing skills.
* Advanced problem-solving ability/mentality, technically adept and logical.
* Ability to represent the interests of the group on cross-functional teams.
* Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
* Ability to work with management locally and globally.
* Advanced ability to communicate effectively with peers, department management and cross-functional peers.
* Bachelors degree required, preferably in Science.
* Advanced Degree preferred.

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.

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.