Associate Director, Analytical Development & QC
$186,000–$233,000 year
HybridRedwood City, California, United States
Job Summary
Lead and coordinate QC activities for late-phase and commercial programs, overseeing outsourced testing at CDMOs and contract labs for drug substance, drug product, and stability. Manage quality events including lab investigations, deviations, change controls, and CAPAs while directing method transfers, validations, and specification setting. Author and review commercial QC documents, monitor reference materials, and establish operational metrics to track performance and drive continuous improvement initiatives. Collaborate cross-functionally with CMC, QA, and supply chain teams to ensure regulatory compliance and timely project goals.
Required Qualifications
- Bachelor's degree in a scientific discipline
- 15+ years of experience in pharmaceutical QC operations across development and commercial stages
- Master's degree
- 12+ years of experience (with Master's degree)
- PhD
- 10+ years of experience (with PhD)
- Solid understanding of relevant global and regional regulatory guidelines (FDA, EU, and ICH, etc.) as applicable to QbD, commercial process validation, commercial product launch, commercial manufacture sampling and testing, and post-approval quality control requirements
- Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.)
- Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices
- Small molecule experience
- Ability to multi-task and thrive in a fast-paced innovative environment
Desired Qualifications
- Biologics experience
- Excellent scientific and business communication skills (verbal, written and technical)
- Strong interpersonal/collaboration skills
- Planning skills
- Ability to think critically and creatively
- Ability to work independently to determine appropriate resources for resolution of problems
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