Overview In this role you will lead QC Analytical activities to support GMP manufacturing and regulatory readiness. You'll optimize and validate analytical methods, investigate deviations, and act as a subject-matter expert across cross-functional teams. Your work ensures data integrity and high-quality analytics for drug substance, drug product, and in-process testing. This is a hands-on leadership position at a cGMP facility with regulatory engagement and continuous improvement focus.
Compensation / Benefits- Medical, Dental and Vision Insurance
- PTO and holidays
- 401(k) match and company contribution
- Life insurance
- Annual Corporate Bonus
- Long Term Incentive Plan
Responsibilities- Ensure data integrity for all QC Analytical data and support equipment validation, maintenance, and calibration
- Perform in-process and release QC testing of cell-based products
- Oversee method qualification, validation, and transfer including protocols, reports, troubleshooting, and optimization
- Conduct routine record review for in-process testing, drug substance/product release and stability
- Author and review SOPs, qualification/validation protocols and reports
- Investigate OOS results, manage deviations and CAPAs related to analytical procedures
- Prepare data packages for regulatory interactions and participate in Pre-Approval Inspections
- Provide SME support for manufacturing investigations including root cause analysis and corrective actions
- Support commercial readiness initiatives, electronic GMP systems, and regulatory filings/inspections
- Evaluate new technologies and processes for continuous improvement and GMP readiness
Key requirements- PhD, MS or BS in Cell Biology or equivalent
- PhD with 6+ years, MS with 8+ years or BS with 10+ years in QC or equivalent pharma industry experience
- Strong experience in developing, optimizing, qualifying and validating analytical cell-based assays
- Proven leadership, independence, prioritization and multitasking in a matrix environment
- Excellent verbal and written communication, analytical and organizational skills
- Working knowledge of regulatory guidance (ICH, FDA, EMA) and cGMP facility experience
- Background in QC Analytical at biotech/pharma with site licensure and commercial readiness activities
- leadership
- strong communication
- problem-solving
- Analytical Cell-based Assays
- Method Qualification/Validation
- OOS investigations
