Associate Director, Quality Control – Analytical Sciences

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 to join the QC Analytical Sciences team in Analytical Development & Quality Control to lead the execution and provide technical and operational oversight of analytical testing to support product development and quality control activities across Apogee’s pipeline. This role focuses on performing and supporting QC testing, method lifecycle activities, and data review to ensure compliance with cGMP and regulatory requirements. Working closely with cross-functional teams and external partners, this individual will be an important member of the TechOps team, contributing hands-on expertise to product release, stability programs, and regulatory submissions across the development pipeline, by managing multiple parallel activities at all stages of product development. Key Responsibilities Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations. Partner with global and cross-functional teams to ensure successful implementation of harmonized methods. Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements. Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues. Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines. Generate and review technical documents, including protocols, reports, and method lifecycle documents. Ideal Candidate Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field) 7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required) Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections 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 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $165,000 - $185,000. 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 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 We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave 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 E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. 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. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.