Senior Director, Quality Control Analytical Sciences

Senior Director, Quality Control Analytical Sciences

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to lead QC Analytical Sciences across Apogee's pipeline. This individual will be an important leader driving the TechOps and CMC Regulatory strategy, reporting to the VP of Analytical Development and Quality Control.

Key Responsibilities

• Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing; in-process / release / stability testing; specification justification and maintenance; shelf-life management; and critical documentation
• Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
• Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
• Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
• Monitor data trends, troubleshoot QC method performance, and investigate OOT / OOS results

Ideal Candidate

The anticipated salary range for candidates for this role will be $245,000-$260,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

A great culture, grounded in our C.O.R.E. values : Caring, Original, Resilient and Egoless

Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

Flexible PTO

Two, one-week company-wide shutdowns each year

Commitment to growing you professionally and providing access to resources to further your development

Apogee offers regular all team, in-person meetings to build relationships and problem solve