Scientist, QC Compliance, Cell Therapy

Biopharma Careers; Bothell (WA); On-site; USD 108,000 - 131,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Global Shutdown between Christmas and

Health & dental benefits

Job summary

BMS in Bothell, WA is seeking a Scientist, QC Compliance to lead and author QC deviations, investigations and CAPAs for cell therapy programs. You will own deviations, investigation reports, change controls, and contribute to APQR sections as needed.

You will work with global regulatory standards, perform root cause analysis, mentor staff, and represent the department during inspections, delivering KPI reports and ensuring timely closure of quality events.

Qualifications

• Knowledge of global regulatory and cGMP requirements.
• Strong technical writing skills.
• Experience with quality management systems.
• Laboratory/biomanufacturing investigations and root cause analysis preferred.

Responsibilities

• Lead and author QC deviations, investigations, CAPAs and change control.
• Work with QC SMEs to conduct root cause analysis.
• Ensure timely, compliant closure of investigations and CAPAs.
• Generate and report KPIs and escalation of at-risk items.
• Train and mentor others on deviation, investigation, CAPA and change control processes/procedures.
• Represent department in inspections.

Skills

Regulatory compliance

CAPA investigations

Root cause analysis

Documentation/writing

Cross-functional communication

Education

Bachelor's degree in science/engineering

Job description

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.

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.
• 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/

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.

R1605887 : Scientist, QC Compliance, Cell Therapy