Principal, Quality Control
$148,000–$185,000 year
On-site · Bothell, Washington, United States
Job Summary
Principal, Quality Control responsible for providing SME-level oversight of analytical method qualification/validation, regulatory submission authoring (IND/BLA), and GMP-compliant QC activities for cell therapy products. Leads design and execution of method validation strategies for cell-based, flow cytometry-based, and PCR-based release and stability assays; oversees method transfers; ensures regulatory readiness and inspections support; contributes to CCS and other regulatory filings; drives continuous improvements in QC methods and testing efficiency; collaborates with Analytical Development, Manufacturing, MSAT, Regulatory, QA, and external partners. Requires extensive experience in GMP biopharma, cell therapy QC, and regulatory submissions; proficient in writing CMC sections and contributing to ready-to-inspect programs. Preferred background includes MSc in life sciences and 10-15 years of related experience.
Required Qualifications
- Minimum of 10-15 years of GMP biopharmaceutical operations experience
- Experience in cell therapy QC analytical methods (flow cytometry, PCR)
- Experience supporting BLA submissions/regulatory filings and inspections
- Experience authoring CMC quality sections for IND and BLA
- Strong GMP laboratory operations knowledge and ICH guidelines
- Ability to lead method qualification/validation programs and deviations/CAPAs
- Excellent communication and cross-functional collaboration skills
- Preferred MSc in Biology or related field with extensive experience
Desired Qualifications
- 10-15 years of GMP biopharmaceutical operations experience
- cell therapy QC analytical methods experience (flow cytometry, PCR-based assays)
- experience supporting BLA submissions and regulatory filings
- ability to author CMC sections for IND/BLA submissions
- leadership in method validation/qualification
- cross-functional collaboration across Regulatory, QA, Manufacturing
- experience with GMP regulatory inspections and Deviations/ CAPAs
- MasterControl or LIMS familiarity
- excellent communication and project leadership skills
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