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 Quality Control Scientist is responsible for supporting Quality Control bioanalytical testing for the release of clinical and commercial products. 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. This is a Sunday-Wednesday position with working hours 8:00am-6:30pm.
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 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.
Duties and 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.
- Complete all work in a timely manner.
Perform peer review of testing data.
- 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.
· 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.
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.
Education and Experience
- Bachelor’s degree required, preferably in Science.
- Advanced Degree preferred.
- 5-8 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.
- 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.