Scientist, QC Compliance, Cell Therapy

Bristol-Myers Squibb; Bothell (WA); On-site; USD 108,000 - 131,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

Paid holidays

Volunteer days

Job summary

Bristol Myers Squibb in Bothell, WA is seeking a subject matter expert to lead and author QC deviations, investigations, CAPAs and change controls within a fast-paced QA team.

The role emphasizes regulatory compliance, root-cause analysis, and mentorship, with collaboration across cross-functional teams and preparation for external inspections.

Qualifications

• Bachelor’s degree in science, engineering, or related discipline.
• 6+ years of experience in biopharmaceutical or QC lab operations with 2+ years of investigation experience.
• Knowledge of cell therapy analytical and microbiological testing preferred.
• Experience with Quality management systems.
• Strong technical writing skills.
• Experience in laboratory/biomanufacturing investigations and root cause analysis techniques preferred.

Responsibilities

• Lead and author QC deviations, investigations, CAPAs and change controls.
• Work with QC SMEs to conduct root cause analysis and ensure timely closure of investigations, deviations, CAPAs and changes.
• Generate and report KPIs and escalate at-risk items.
• Own document revision, CAPA and deviation/investigation/change management.
• Mentor others on deviation, investigation, CAPA and change control processes.
• Represent department in internal and external inspections.
• May support authoring of APQR sections.

Skills

Regulatory compliance

cGMP knowledge

Root cause analysis

Quality writing

Education

Bachelor’s degree in science/engineering

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.

Position Summary

Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change control. May support authoring of APQR sections for QC.

Duties/Responsibilities

Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change control. Work with QC SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls. Generate and report KPIs. Highlight and escalation at risk items. Analyze and report CAPA effectiveness. Own document revision, project, CAPA and deviation/investigation, change management and/or continuous improvement efforts. Train and mentor others on deviation, investigation, CAPA and change control process/procedures. Represent department in internal/ external inspections. May support authoring of APQR sections. Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums).

Qualifications

Specific Knowledge/Skills/Abilities: Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Advance problem-solving ability/mentality, critical thinking, technically adept and logical. Advance 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, action oriented, highly organized to meet deadlines and prioritize work. Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.

Education/Experience/Licenses/Certifications

Bachelor’s degree in science, engineering, or related discipline. 6+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required. An equivalent combination of education and experience may substitute. Knowledge of cell therapy analytical and microbiological testing preferred. Demonstrated experience with Quality management systems. Demonstrated strong technical writing skills. Demonstrated experience in laboratory or biomanufacturing. investigations and root cause analysis techniques preferred.

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

Bothell - WA - US: $108,280 - $131,212 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.

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/

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] 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.

R1605887 : Scientist, QC Compliance, Cell Therapy Data Privacy Link

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.