Pharmaceutical powerhouse is looking to bring on an Associate Director of Quality Control. Located just outside of the scenic tech hub of Seattle!
- Manage QC staff including recruiting, onboarding, and performance management.
- Provide input on budget and resources
- Ensure all project team deliverables are met for outsourced QC work including lot release, stability testing, method validation/transfer/verification, reference standard qualification and analytical comparability
- Continue to build a strong interface to Analytical Development to ensure seamless transfer of analytical methods into QC labs and subsequent phase appropriate validation of such methods
- Interface with and build strong collaborative relationships with external stakeholders (CMOs or contract labs) and internal stakeholders including development (upstream, downstream and formulation), CMO and Project Management, Regulatory CMC, and Quality Assurance
- Ensure compliance within QC by monitoring test methods, SOPs, and QC analytical data to cGMPs, pharmacopeial and regulatory requirements
- Review and approve deviations, laboratory investigations and evaluate proposed analytical change requests
- Partner with Analytical Development to develop and execute analytical comparability protocols to support process changes
- Oversee QC contributions to regulatory flings including review of regulatory applications (clinical and marketing applications), review of responses to information requests, and review of briefing documents; develop and implement plans to address gaps based on regulatory feedback or country specific testing requirements
- Bachelor's Degree in biochemistry, chemistry, analytical chemistry, biology, or related field
- 8+ years' experience in Quality Control or other related function within a biologics/pharmaceutical company
- 2+ years people management experience
- Experience interfacing with Monochromal Antibodies