Director, Quality Control

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, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

If this sounds like you, keep reading!

Role Summary

We are seeking a Director of Quality Control (QC) to oversee technical and operational and aspects of Quality Control across Apogee’s pipeline. This individual will be an important member of the Tech Ops team, managing multiple parallel activities at all stages of product development.

 Key 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

 Ideal Candidate 

• 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: Caring, Original, Resilient and Egoless
• Position requires up to 20% travel

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The anticipated salary range for candidates for this role will be $190,000-$225,000. 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. 

What We Offer

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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