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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. Read more: careers.bms.com/working-with-us.
Title: Manager, Clinical QC - Critical Reagents
Location: Warren, NJ
The Manager of QC Critical Reagent Operations is managing QC Materials Operations which includes but not limited to preparation and qualification of Assay Controls, Standards, and critical reagents. The manager for Critical Reagents team will be overseeing the daily lab activities, related to in-process, final release, and stability testing of cell therapy critical reagents. Develop and execute a work plan for the team, ensuring safety, quality, and performance targets are achieved. Track, trend, and report key performance metrics.
Key Responsibilities:
- Provide direct management of the Critical Reagents QC team and oversee the daily lab activities through on the floor presence.
- Develop and execute a work plan for the team, ensuring safety, quality, and performance targets are achieved. Track, trend, and report key performance metrics.
- Perform QC data review ensuring results are compliant with specifications and regulations.
- Review and approve (test methods, procedures and) laboratory records in alignment with company policies and procedures.
- Own and evaluate investigations, deviations and CAPAs.
- Hire, coach, mentor and develop team members to support the business operations and employee career development. Resolve personnel conflicts in the workspace.
- Lead team meetings and support cross functional operational meetings. Act as a point of contact for all work in the assigned area and ensures appropriate shift handover.
- Communicate effectively including escalations and cascades of critical information to ensure effective business operations.
- Provide performance evaluations and support development of direct reports (team members)
- Ensure employees are properly trained and qualified to perform assigned tasks.
- Identify and mitigate risks in QC lab that could negatively impact the lab operations, safety, compliance.
- Promote RFT culture and drive continuous improvement initiatives through staff engagement.
- Provide leadership support during troubleshooting of assay performance and equipment as it relates to ensure product quality and compliance.
- Ensure laboratory is in state of inspection readiness at all times. May support internal and external inspections.
- May Apply technical & operational knowledge to perform troubleshooting and problem solving for non-routine & complex operational issues.
- Perform other tasks as required to support the QC laboratories.
- Ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.
- Strong leadership, coordination and communication skills.
- Ability to work collaboratively in a high-paced team environment, meet deadlines and prioritize work from multiple activities.
- Advanced problem-solving ability/ mentality, technically adept, logical and detail oriented.
- Strong mentoring/ coaching, influencing, negotiating and personnel interaction skills.
- Ability to apply Lean, Six Sigma and Risk Management concepts and tools preferred
Qualifications & Experience:
- Bachelor's degree or equivalent required, preferably in science. Advanced Degree preferred.
- 6 -8+ years of relevant laboratory work experience, preferably in a regulated environment. An equivalent combination of education and experience may substitute.
- 0-2+ years of leadership experience preferred o Preferred Experience with various bioanalytical techniques (cell based assays, ELISA, qPCR, flow cytometry) and associated equipment preferred.
- Working knowledge of quality management systems
- Working knowledge and implementation of data integrity principles preferred
- Knowledge of LIMS, ELN and laboratory data analysis systems preferred.
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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
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/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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