Qlty Assurance Methods
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Purpose and Scope of Position
The QC Scientist is responsible for supporting compliance related activities within the S12 Quality Control department in direct support of clinical and commercial CAR T manufacturing activities. This includes the ability to interface with cross functional groups, independently perform tasks, interpret results, author protocols/reports, conduct thorough root cause investigations (including hypothesis testing), identify robust corrective and preventive actions (CAPA) and troubleshoot complex problems. Additionally, the QC Scientist will be responsible for continuous improvements, and change management within the QC department.
Required Competencies: Knowledge, Skills, and Abilities
- Advanced knowledge of deviation investigations utilizing root cause analysis tools.
- Knowledge of CAPA process and ability to identify and verify effectiveness.
- Knowledge of change management and associated change control processes.
- Advanced technical writing skills and ability to collaborate effectively with cross function team.
- Advanced ability to accurately and completely understand, follow, interpret, apply Global
Regulatory and cGMP requirements.
- Ability to support health authority inspections.
- Knowledge of data trending and tracking, including use of statistical analysis software a plus.
- Demonstrate advanced problem solving ability / mentality, technical adeptness and logical thinking.
- Ability to set priorities, manage timelines and effectively react/manage changing priorities.
- Ability to work with management (global and site) and support corporate and departmental goals.
- Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
- Hands on experience with various analytical techniques including: flow cytometry, PCR, and other immunoassays (preferred).
Duties and Responsibilities
- Conduct thorough investigations (OOS, OOT, environmental monitoring, deviations, etc.) utilizing root cause analysis tools.
- Identify effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
- Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
- Initiate change control documentation and assist other QC functional groups with change management documentation.
- Identify functional area SMEs to perform impact assessments as part of the change management process.
- Ensure all investigations, CAPAs and change controls are completed in a timely manner.
- Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
- Support QC during audits and site inspections for QC compliance related inquiries.
- Handle complex issues and solve problems with minimal guidance.
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Support manufacturing and Quality Control testing of CAR-T products as needed.
- Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
- Continuously support QC, living the “patients first” mission and fostering a “Right First Time” mindset.
Education and Experience
- Requires a Bachelor’s Degree in Biochemistry, Immunology, Molecular and Cellular Biology, Biology or related discipline (advanced degree preferred).
- 5+ years of relevant work experience, preferably in a health authority regulated environment.
- Previous experience in a gene or cell therapy facility is preferred (CAR-T a plus).
- An equivalent combination of education and experience may substitute.
- The incumbent will be working 60% to 75% of the time in an office environment.
- The incumbent will be working 25% to 40% of the time in a manufacturing and/or laboratory setting.
- The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
- The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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 the resources to pursue their goals, both at work and in their personal lives.