Director, Quality Control

Summary

Join Apogee Therapeutics, a Nasdaq-listed biotechnology company, as their Director of Quality Control. You will oversee QC technical and operational aspects across the company's pipeline, managing multiple activities at all product development stages. This role involves building and maintaining QC infrastructure, establishing partnerships with external labs, and ensuring compliance with global GMP requirements. You will contribute to setting specifications, investigate unexpected results, and author/review analytical method reports. Close collaboration with internal and external stakeholders is crucial. The position requires significant experience in QC/analytical development with complex biologics and a deep understanding of analytical methods.

Requirements

• Advanced degree, PhD preferred, in a relevant discipline (e.g., analytical chemistry, biochemistry or related field)
• 10+ years of QC/analytical development experience with complex biologics spanning early, late-stage and commercial development
• Deep understanding of critical quality attributes, and analytical methods used to test (e.g., HPLC, CE, ELISA) for biologics
• Expertise in global expectations for analytical method validation and transfer
• Experience with processes and materials supporting QC testing, such as reference standards and qualified materials
• Excellent communication skills with an ability to collaborate effectively across functional lines
• Ability to work independently and multi-task in a fast-moving organization
• Availability to participate in calls across multiple international time zones
• Successfully exhibit Apogee’s C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Position requires up to 20% travel

Responsibilities

• Build and maintain QC technical infrastructure and an external network to support release and stability testing of globally approved commercial biologics
• Establish and manage partnerships with external QC labs, coordinate all testing activities and deliverables; oversee analytical method validation/transfer
• Contribute to the setting of release/stability specifications, investigate and troubleshoot unexpected results, and ensure consistency of results and specifications across testing network
• Author/review analytical method reports and relevant sections of global regulatory filings
• Stay up to date on global GMP testing requirements and guidance
• Execute testing strategies for moving products from early through late-stage development to commercialization in global markets
• Work closely with Manufacturing & Development partners within Apogee Tech Ops, as well as external stakeholders, to execute QC activities according to program needs

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• 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