Bristol Myers Squibb Company

Scientist or Senior Scientist, Quality Control Cell Therapy

Location
Celgene, NJ, United States
Posted
Sep 05, 2020
Ref
R1527924
Required Education
Bachelors Degree
Position Type
Full time
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.

Purpose and Scope of Position

The Scientist or Senior Scientist Quality Control (QC) is responsible for supporting bioanalytical release testing for clinical and development products, QC analyst training, analytical method transfer to QC and deviation investigation. The Scientist/Senior Scientist should be able to work corssfunctionally with multiple groups (such as analytical development, ECQ and quality assurance) and has the ability to to independently carry out laboratory based analytical methods, interpret results, and troubleshoot.Activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operational procedures.

Required Competencies: Knowledge, Skills and Abilities
  • Advanced hands-on experience with various analytical techniques including but not limited to ELISA, qPCR, FACS and scientific knowledge in method qualification and method transfer.
  • Deep understanding of Flowcytometry based methods, instrument operation and troubleshooting.
  • 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 set priorities of the group and manage timelines.
  • Advanced ability to communicate effectively with peers, department management and cross-functional peers.
  • Capable of handling complex issues and solving problems with minimum guidance.
  • Proficiency in analytical skills: indepent execution, statistical analysis and effective presentation of analysis to other groups.
  • Strong verbal and written communication skills and interpersonal skills.


  • Duties and Responsibilities
  • Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
  • Complete necessary training to become a qualified trainer.
  • Provide training to QC analysts and oversee method execution. Document training per procedural and cGMP requirements.
  • Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
  • Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
  • Have good communication skills and be able to work cross-functionally with ECQ, QA and analytical development.
  • Ensure proper operation and perform routine maintenance of all laboratory equipment. Ensure that all equipment and personnel are remain in compliance with cGLP/cGMP, FDA/EMA requirement, appropriate SOPs and corporate policies.
  • Perform testing of in-process, final product, and stability samples.
  • Complete all work in a timely manner. Complete all reviews in accordance with required release timelines.
  • Perform peer review of testing data. Review all data in accordance with applicable procedures and cGMP requirements.
  • Perform tracking/trending of data to contribute to the life-cycle management of an analytical method.
  • Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
  • 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.
  • Performs other tasks as assigned. Maintain a safe workplace in accordance with company and OSHA policies/procedures.
  • Maintain a basic knowledge of cell therapy development and awareness of competitive landscape.


Education and Experience
  • Bachelor's degree required, preferably in Science.
  • Advanced Degree preferred.
  • Minimum 5-10 years (Scientist) or 10-15 years (Senior Scientist) of relevant work experience, preferably have method development and support experience.


Working Conditions
  • The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
  • The incumbent must analyze numerical values on a daily basis.
  • The incumbent will be working a laboratory setting, up to six (6) hours per day.
  • The incumbent will be working around biohazardous materials, including chemical agents up to six (6) hours per day.


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.