Senior Specialist, QC Analytical

Biopharma Careers; Summit West (CA); On-site; USD 117,578,000 - 142,168,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary incentive programs

Stock opportunities

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, QC Analytical, to support the CAR T Manufacturing facility in Summit, NJ. You will perform routine testing of in-process, final product, and stability samples, and review GMP documentation with minimal supervision.

Requires strong cell biology skills, cGMP knowledge, and data analysis expertise. Collaboration with cross-functional teams is essential in a fast-paced environment.

Qualifications

• Bachelor’s degree in Science; advanced degree preferred.
• 4+ years of analytical testing or QC experience in a regulated environment.
• Experience with cell-based assays and analytical methods.

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Anticipate and perform routine troubleshooting with minimal guidance.
• Perform data verification and review of GMP documentation for methods.

Skills

Cell & molecular biology

cGMP compliance

Technical writing

Problem solving

Communication

Fast-paced teamwork

LIMS/ELN knowledge

Education

Bachelor's degree in Science

Advanced degree preferred

Tools

LIMS

ELN

Lab data analysis systems

Job description

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.

The Senior Specialist position is responsible for performing routine testing of in-process, final product, and stability samples in accordance with BMS policies, standards, procedures, and Global Regulatory and cGMP requirements to support the Quality Control Analytical department in the Bristol Myers Squibb (BMS) CAR T Manufacturing facility located in Summit, NJ. Additionally, this role performs data review for general and complex methods to support final drug product release. This position requires high problem-solving skills/mentality with minimal guidance, the ability to interface with multiple cross functional groups, as well as the ability to work in a fast-paced team environment.

Shift Available

Wednesday-Saturday 1:30pm-11:30pm

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.

Knowledge & Skills

• Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).
• 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.

Minimum Requirements

• Bachelor’s degree or equivalent required, preferably in Science. Advanced degree preferred.
• 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.

Working Conditions

• Ability to lift up to 45 lbs at floor and waist height (commonly Ability to operate and handle scissor lift carts requiring 15-20 lbs of initiation force.
• Ability to perform frequent pipetting and laboratory tasks within a biological safety cabinet, including prolonged seated work.
• Ability to independently don, doff, and wear required PPE (e.g., lab coat/frock, gloves, safety shoes, eye/face protection) during work shift, including cryogenic gloves as needed.
• Ability to safely handle chemical disinfectants, flammable materials, and hazardous chemicals.
• Work may involve handling liquid nitrogen and other cryogenically cooled materials.
• Ability to use step stools to reach and handle materials.

Compensation 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.

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.

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 [e-mail] 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.

R1604963 : Senior Specialist, QC Analytical