Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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.
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 Scientist is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This 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, including Quality Assurance teams.
Shift 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 investigations and cross functional investigation teams, and close reports in a timely manner
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 product or 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. •Support deviation investigation defense during audits and site inspections for QC compliance related inquiries.
Handle complex issues and solve problems with minimal guidance.
Provide training to new investigations team 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 kickoff 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/engineers 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.
Working experience in the CAPA process and ability to identify and verify effectiveness.
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.
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.
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.
Ability to train new team members on the investigation process.
Additional Qualifications/Responsibilities
Basic Requirements:
Requires a Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred). An equivalent combination of education and experience may substitute.
Minimum 3 years of investigations experience within a cGMP facility.
Minimum 3 years of Manufacturing or Quality experience within a cGMP facility.
Working experience of deviation investigations utilizing root cause analysis tools.
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.