New · posted Nov 11
Bristol Myers Squibb · Biotechnology
Senior Specialist, QC Analytical, Cell Therapy
- Summit West, NJ
- On-site
- Full-time
- Senior & Principal
The role
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.
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.
Reporting Relationship
- This position will report to QC management.
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.
What you need
Specific Knowledge, Skills, Abilities
- 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.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
What you'll do
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.
Pay
$85,218 – $103,251 a year
Employer provided$40.97 – $49.64 an hour · yearly at 2,080 hours (40 a week)
How this comparesCompensation Overview
Summit West - NJ - US: $40.97 - $49.64per 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.
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
Where you'll work
Summit West, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Summit West, NJSchedule and working conditions
Days
Hours
Equal opportunity, accessibility and legal noticesBristol Myers Squibb's statements, word for word
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 [email protected]. 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.
If this posting is missing required information required by local law or incorrect, contact BMS at [email protected]with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1608303 : Senior Specialist, QC Analytical, Cell Therapy
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Quality Control roles at this level.
This roleEmployer provided
Senior & Principal roles in New Jersey8 roles publishing pay
Senior & Principal roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $85,218 | — | $103,251 |
| New Jersey (middle half) | $89,375 | $97,500 | $102,125 |
| All US (middle half) | $89,000 | $95,000 | $108,500 |
This role: Bristol Myers Squibb's own published range, converted to a year at 2,080 hours. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 265 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Bristol Myers Squibb's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods8
- Documentation and SOPs7
- Collaboration and leadership7
- GMP and compliance3
- Investigations and CAPA2
- Validation and qualification2
- Quality systems and risk2
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- ICHICH Q5 and Q6B(official source, opens in a new tab)Quality of biotechnological products and their specifications
Company hiring pulse
Bristol Myers Squibb on Regulatory Jobs
- 61
- Open roles
- 61
- Distinct roles
- 11
- Locations
By discipline
- Quality43 70%
- Clinical13 21%
- Regulatory5 8%
By level
- Associate & Specialist18 30%
- Senior & Principal16 26%
- Manager14 23%
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Senior Specialist, QC Analytical, Cell Therapy at Bristol Myers Squibb
Applications close December 31. $85K–$103K a year, employer provided.