Manager, QC Scientist

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.

The QC Scientist is responsible for supporting the release of critical reagent to support clinical and commercial manufacturing. This department is responsible for Flow Cytometry based testing for stability, validation, critical reagent qualification, concentration determination, 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.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
  • 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 skill s .
  • Advanced problem - solving ability/mentality, technically adept and logical.
  • Ability to represent the interests of the gro u p on cross - functional team s .
  • 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 globall y .
  • Advanced a bi li t y to communicate effectively with peers, department management and cros s -functional peer s .
  • 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 skill s .
  • Advanced problem - solving ability/mentality, technically adept and logical.
  • Ability to represent the interests of the gro u p on cross - functional team s .
  • 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 globall y .
  • Advanced a bi li t y to communicate effectively with peers, department management and cros s -functional peer s .


Education and Experience:
  • Bachelor’s degree required, preferably in Science.
  • Advanced Degree preferred.
  • 5-8 y e ars o f 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, antibody titration and flow cytometry data analysis.


DUTIES AND RESPONSIBILITIES:
  • Perform testing on critical reagent and stability samples.
  • Utilize scientific principles to assist in anal y tical testing methods and the proper use of laborato r y equipment.
  • Perform antibody and other critical reagent qualification and titration.
  • 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.
  • Complete all work in a timely manner.
  • 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.
  • Complete all reviews in accordance with required release timelines of reagents
  • Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
  • 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.
  • 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.
  • Performs other tasks as a s signed.


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.

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 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.

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