Senior Scientist, QC Investigations - CTO Global Network
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 Senior Scientist is responsible for supporting compliance related activities within the Network Quality Control department in direct support of clinical and commercial CAR T manufacturing operations. This includes the ability to interface with cross functional groups, independently perform tasks, interpret results, author protocols/reports, conduct thorough root cause investigations (including experiment design and hypothesis testing), identify robust corrective and preventive actions (CAPA) and troubleshoot complex problems. Additionally, the Senior Scientist will be responsible for continuous improvements, and ownership of change management records within the QC department.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Advanced working experience of Handling the deviation investigations utilizing root cause analysis (RCA) techniques and CAPA handling.
- Working experience in the CAPA process and ability to identify and verify effectiveness.
- Working experience in the change management and associated change control processes.
- Advanced technical writing skills and ability to collaborate effectively in cross functional teams.
- Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
- experience supporting health authority inspections.
- Knowledge of data trending and tracking, including use of statistical analysis software.
- 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.
- Ability to utilize electronic Quality systems such as Veeva, Trackwise
- Combination of knowledge and hands on experience with various analytical techniques such as ELISA, qPCR, Cell Concentration, Sterility, Mycoplasma, Endotoxin, flow cytometry, HPLC/UPLC, FTIR, pH, Osmometer, Particle Size Enumeration, USP/EP Procedures and Environmental Monitoring.
- Ability to mentor junior associates to foster and develop their expertise.
Education and Experience:
- Requires a bachelor’s degree in science, preferably in Biochemistry, Analytical Chemistry, Molecular and Cellular Biology, Biology, or related discipline (advanced degree preferred).
- 9+ 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.
DUTIES AND RESPONSIBILITIES:
- Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, CAPA etc.) utilizing root cause analysis tools.
- Perform GEMBA walks with stakeholders to better understand process steps, and evaluate the need to make process improvements, with the coordination of Subject Matter Experts.
- 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. Notify stakeholders of any delays in a timely manner.
- Support QC during audits and site inspections for QC compliance related inquiries.
- Handle complex issues and solve problems with minimal guidance.
- Provide mentorship, guidance and training to junior members.
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Support and triage Quality Control events including multisite and local labs
- 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.
WORKING CONDITIONS (US Only):
- The incumbent will be working 60% to 70% of the time in an office environment.
- The incumbent will be working 30% 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 based on business needs.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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