Scientist, QC Compliance, Cell Therapy

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 escalate 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

• 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 and Experience

• 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.

Pay

Bothell - WA - US: $108,280 - $131,212. The starting pay range listed is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities.

Schedule

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. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). 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.