Specialist, Investigations, Cell Therapy
About The Position
The Specialist, Investigations, Cell Therapy leads and supports deviation investigations within a cGMP-compliant cell therapy manufacturing environment. The role ensures investigations are timely, thorough, and scientifically sound, and drives effective corrective and preventive actions (CAPAs) to support continuous improvement and compliance with regulatory expectations. The position works with Manufacturing, Quality Assurance, Quality Control, Engineering, and other departments to investigate issues and implement and verify CAPAs. It reports to the Senior Manager, Investigations, Cell Therapy, within the site Manufacturing Science & Technology department. The listed schedule is Monday through Friday, 8 a.m. to 5 p.m. The position may involve working in a clean-room manufacturing environment approximately 15% of the time; the remainder is in an office environment.
Requirements
- Bachelor’s degree in science, engineering, biochemistry, or a related discipline, or equivalent knowledge attained through studies.
- 1–3 years of experience in biopharmaceutical operations, or equivalent.
- Familiarity with investigation processes, CAPA systems, and quality documentation.
- Strong attention to detail and organizational skills, with the ability to manage multiple priorities.
- Effective communication and interpersonal skills for collaboration across teams.
- Understanding of Quality Risk Management and Operational Excellence principles.
Nice To Haves
- Proficiency in Microsoft Office.
- Experience with electronic quality systems such as Infinity, TrackWise, or Veeva.
Responsibilities
- Conduct and manage root-cause investigations as a Lead Investigator, including impact assessments and CAPAs.
- Draft investigation reports and CAPAs that are clear, accurate, and compliant with internal procedures.
- Document investigation activities accurately and in a timely manner in compliance with cGMP and internal procedures.
- Coordinate investigation activities with Manufacturing, Quality Assurance, Quality Control, Engineering, and other departments.
- Track and support CAPA implementation, including scheduling, documentation, and verification of effectiveness.
- Participate in continuous improvement initiatives by identifying recurring issues and contributing process-enhancement ideas.
- Stay current with investigation procedures, regulatory expectations, and quality systems through ongoing training and development.
Benefits
- Comprehensive benefits, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
- Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
- For applicable employee groups, 160 hours of paid vacation annually for new hires, subject to manager approval.
- 11 paid company holidays; applicable non-exempt, RayzeBio, and Puerto Rico employees also receive 3 optional holidays.
- Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year’s Day.
- Potential eligibility for additional discretionary cash incentives and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
