Associate Director, QC Manufacturing Support

Apogee Therapeutics, Inc. - Common Stock

RemoteRemotePosted January 27, 2026

Job Description

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.

We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.

If this sounds like you, keep reading!

Role Summary

We are seeking an Associate Director, QC Manufacturing Support to provide GMP raw materials testing program management and to additionally support drug substance process-related analytical testing activities as a liaison to Apogee’s DS, DP, and MSAT teams. The ideal candidate has deep technical expertise and understanding of GMP raw materials QC testing management and regulatory expectations, is competent and experienced operating in GMP quality management systems and has experience with analytical in-process testing for biologics (e.g., protein concentration, titer, etc.).

Responsibilities may include:

Author internal raw materials testing specifications, specifically for non-compendial raw materials
Assess test methods being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation
Perform change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites
Review and assess impact of vendor change notifications related to GMP raw materials; partner with internal and external stakeholders to development plans for material changes with major impact
Provide general analytical support to DS, DP, and MSAT teams in conjunction with QC Analytical Sciences on coordination and execution of in-process analytical testing; may include review of manufacturing-related sampling/testing plans, supporting materials and process-related risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management
Interface with internal and external stakeholders to support manufacturing campaigns at CDMOs, including supporting requests for information, document review, and audits/regulatory inspections as required
Support deviations, OOS/OOT/OOE investigations, and CAPAs related to GMP raw materials and in-process testing

Preferred Qualifications:

BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, etc.)
10+ years of biotech industry experience in QC operations or analytical support roles with at least 6 years demonstrated experience supporting a GMP raw materials testing program
Understanding of analytical techniques relevant to monoclonal antibody testing
Experience in relationship management with external analytical test sites
Ability to effectively prioritize and manage multiple projects&l

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