Senior Specialist QC Microbiology Cell Therapy

Bristol Myers Squibb; New Jersey; In loco; USD 56.000 - 68.000; Tempo pieno

Descrizione del lavoro

Bristol Myers Squibb in Summit West, NJ, is seeking a QC specialist to support in-process, final product, and stability testing, plus environmental monitoring. The role involves troubleshooting, data verification, and documentation revisions in a fast-paced GMP environment.

The position requires a science degree and 4+ years of microbiology/QC experience, with strong writing and cross-functional collaboration skills. The shift is Sun-Wed 1pm-11:30pm, full-time, onsite in New Jersey.

Competenze

• Bachelor's degree in science or equivalent required; advanced degree preferred.
• 4+ years of microbiological testing or QC experience in a regulated environment.
• Demonstrated experience with microbiological techniques and GMP requirements.

Mansioni

• Perform method transfer/verification/validation and routine testing of samples.
• Support environmental and facilities monitoring and data review/verification.
• Review GMP documents and perform deviations/investigations/CAPA tasks.
• Train and mentor others on QC test methods and processes.
• Participate in continuous improvement initiatives and projects.
• Perform other tasks as assigned.

Conoscenze

QC testing

Microbiology techniques

Data verification

cGMP knowledge

Technical writing

Problem solving

Communication

Team collaboration

Formazione

Bachelor's degree in science

MLO level 4 (Netherlands)

Advanced degree preferred

Strumenti

LIMS

ELN

Laboratory data analysis systems

Descrizione del lavoro

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, stability samples and for supporting environmental and facility monitoring, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.

Shift: Sun-Wed 1pm-1130pm

Duties/Responsibilities

• Perform method transfer/ verification/ validation, routine testing of in process, final product, and stability samples. Perform environmental/facilities monitoring and microbiological testing.
• 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.

Qualifications

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.

Education/Experience/ Licenses/Certifications:

• Bachelor's degree or equivalent required, preferably in science. Advanced degree preferred. Netherlands: MLO level 4 required.
• 4+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience with microbiological techniques

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.

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.

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