Sr. Manager/Associate Director, Analytical Development & Quality Control
Tasks
- Define analytical control strategy
- Define sampling strategies
- Develop analytical development and quality control strategy
- Develop analytical platforms and reference standards
- Direct OOS OOT deviation investigations
- Ensure CAPA effectiveness
- Ensure cGMP GLP regulatory compliance
- Govern analytical lifecycle integration
- Govern shared laboratory infrastructure equipment lifecycle scheduling resource allocation
- Implement digital solutions automation and continuous improvement
- Lead QC laboratory operations for in process release stability testing
- Lead analytical method development qualification validation transfer lifecycle management
- Lead aseptic processing contamination control and microbiological monitoring
- Lead cross functional alignment on analytical strategy and readiness
- Lead method transfer and performance monitoring
- Lead team coaching performance management and succession planning
- Maintain inspection readiness
- Monitor performance metrics
- Oversee GMP and non GMP segregation
- Oversee LIMS analytical systems and data integrity ALCOA+ Part 11
- Oversee environmental monitoring trending control strategies
- Oversee stability strategy trending shelf life justification
- Serve as inspection SME for analytical and QC
- Support analytical readiness and batch disposition
- Support proposals scope definition and client program execution
- Support regulatory filings and analytical justifications
Perks/Benefits
- N/A
Skills/Tech-stack
ALCOA plus | Analytical Development | Aseptic Processing | Automation | CAPA | CGMP | Cell-based potency assays | Contamination control | Data Integrity | DdPCR | ELISA | Empty Full Capsid Analysis | Environmental monitoring | Flow Cytometry | GLP | GMP | Genome Integrity Assays | ICH Q10 | ICH Q14 | ICH Q2 | LIMS | Lifescycle Management | Method transfer | Method validation | OOS Investigations | OOT Investigations | Part 11 | Potency assays | QPCR | Quality Control | Stability Testing | Vector characterization | Viral Vector | Viral vector characterization | Viral vectors
Education
Roles
Associate | Associate Director | Director | Manager | Senior Manager
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