Job Information
Bristol Myers Squibb Senior Scientist, Investigations MSAT in Summit, New Jersey
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At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The Senior Scientist, Investigations Team is responsible for leading manufacturing and QC investigation reports in support of S12 CAR-T operations. The incumbent will be assigned more complex deviation investigations, and often need to create and facilitate teams to execute all elements in a timely manner. Deviation investigation includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA),and troubleshooting complex problems. The successful incumbent must interface closely with different functional organizations and management, including Quality Assurance teams.
Shifts Available:
- Monday - Friday, Onsite Day Shift (9 a.m. - 5 p.m.)
Responsibilities:
Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
Lead medium and high-risk investigation teams with the ability to summarize progress to Sr. Management, collect information from the triage team, and gather necessary supporting data from technical and quality teams outside of S12.
Perform GEMBA walks with stakeholders to better understand process steps, and evaluate Root Cause analysis.
Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
Assess potential impact and risk to productor process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
May Initiate change control documentation.
Identify functional area SMEs to perform impact assessments as part of the change management process.
Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
Lead deviation investigation defense during audits and site inspections for QC compliance related inquiries.
Handle complex issues and solve problems with minimal guidance. Manage teams to support more complex investigations.
Provide mentorship, guidance and training to junior members.
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 S12, living the patients first mission and fostering a Right First Time mindset.
Knowledge & Skills:
Advanced working experience of deviation investigations utilizing root cause analysis tools.
Working experience in the CAPA process and ability to identify and verify effectiveness.
Advanced technical writing skills, and capability to review, improve, and approve investigation reports from more junior team members.
Capability to kick off and lead limited duration investigation teams, to ensure timely completion of more complex investigations requiring scientific work outside of S12 site.
Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
Experience supporting health authority inspections.
Sr. Scientists will often defend more complex investigation reports in Regulatory Investigator questioning during Health Authority audits.
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.
Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.
Proven delivery of complex investigation reports is required for the Sr. Level role.
Ability to train and mentor junior associates to foster and develop their expertise.
Basic Requirements:
Requires a Bachelor'sDegree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
Minimum 5 years of relevant work experience, preferably in a health authority regulated environment.
Sr Level requires demonstrated capability in medium and high-risk deviation reports or equivalent proven experience.
Previous experiences working in a biopharmaceutical manufacturing facility and an aseptic environment is preferred (CART a plus).
An equivalent combination of education and experience may substitute
Working Conditions:
The incumbent will be working 80% to 90% of the time in an office environment.
The incumbent will be working 10% to 20% 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.
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Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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Company: Bristol-Myers Squibb
Req Number: R1584261
Updated: 2024-09-22 02:31:01.677 UTC
Location: Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.