Senior Specialist, QC Analytical, Cell Therapy

Bristol-Myers Squibb Co; New Jersey; On-site; USD 56,000 - 68,000; Full time

Benefits offered by this job

Flexible Time Off

Paid holidays

Paid vacation

Volunteer days

Global Shutdown

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, QC Analytical, Cell Therapy, to support QC testing across in-process, final product, and stability samples. You will review data, troubleshoot methods, train staff, and drive continuous improvement within a fast-paced environment.

The role reports to QC management and requires strong technical writing, GMP knowledge, and collaboration with cross-functional teams to ensure compliance and timely results in Summit West, NJ.

Qualifications

• Ability to accurately understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Perform data verification, data review and review of GMP documentation for general and complex methods.
• Perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train and mentor others on QC test methods, processes and procedures.
• Perform other tasks as assigned.

Skills

Regulatory compliance

Technical writing

Problem solving

Cross-functional communication

Team performance

LIMS/ELN knowledge

Tools

LIMS

ELN

Job description

About the Company

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"- a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.

Shift

Sunday to Wednesday 1:30pm to 11:30pm

Duties/Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Perform data verification, data review and review of GMP documentation for general and complex methods.
• Perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train and mentor others on QC test methods, processes and procedures.
• Perform other tasks as assigned.

Reporting Relationship

This position will report to QC management.

Qualifications

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.

Job Safety Requirements & Essential Physical Demands

• Ability to perform lifting tasks up to 20 lbs (9 kg) at floor and waist height.
• Ability to lift up to 10 lbs (4.5 kg) overhead as well as push or maneuver carts to transport materials between locations.
• Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
• Ability to independently don, doff, and wear required personal protective equipment such as but not limited to lab coat/frock, gloves, safety glasses/face shield for prolonged periods while performing laboratory work.
• Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
• Work may involve handling of dry ice, liquid nitrogen, and cryogenically cooled materials.
• Ability to use step stools while reaching and handling materials.
• Ability to work in a Biosafety Level 2 (BSL-2) environment.

The laboratory employee is responsible for performing work safely in accordance with EHSS procedures. This includes identifying and controlling risks, proper use of personal protective equipment (PPE), safe handling of chemicals and biological agents, compliance with waste and emergency procedures, and active participation in training and safety programs.

Compensation Overview

Summit West - NJ - US: $40.97 - $49.64 per hour

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Why Join Us

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

R1608303 : Senior Specialist, QC Analytical, Cell Therapy Data Privacy Link