Associate Director, GMP Quality Assurance

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 a dynamic and results-driven Associate Director of GMP Quality Assurance (QA) to join our team. You will play a pivotal role in ensuring the quality, safety, and compliance of our biologics manufacturing processes and device development activities (pre-filled syringes, autoinjectors, etc.). This position will work closely with cross-functional teams to establish, maintain, and continually improve Apogee’s quality systems. This role is essential in supporting our mission to develop and deliver differentiated biologic therapies to patients in need.

Key Responsibilities

• Lead and support QA activities for downstream manufacturing, including Drug Product, Finished Drug Product, and devices such as pre-filled syringes and auto-injectors
• Maintain and enhance robust GMP quality systems encompassing documentation, change control, deviations, CAPA, quality events, and continuous improvement initiatives
• Stay current with regulatory changes, industry trends, and implement new requirements into company policies and procedures
• Utilize risk-based approaches to quality management, proactively identifying and mitigating quality risks across the organization
• Develop, monitor, and report key quality metrics to drive GMP compliance and improve product quality
• Ensure all personnel are adequately trained in GMP requirements and quality procedures
• Keep comprehensive and accurate records and reports of all quality assurance activities
• Foster a culture focused on quality, compliance, data integrity, patient safety, collaboration, and teamwork
• Prepare and support the organization for regulatory authority inspections and maintain inspection readiness
• Collaborate with cross-functional teams to solve problems and drive innovation in quality systems and processes

Ideal Candidate

• A bachelor’s degree in relevant scientific discipline or equivalent is required
• A minimum of 7 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in the manufacture of monoclonal antibodies or biologics
• Knowledge of medical device Quality System Regulations with direct experience in 21 CFR Part 4, Part 820, ISO 13485 and ISO 14971.In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements
• Experience with analytical instrumentation, methods, validation, and investigations including stability program management
• Experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
• Demonstrated strong oral and written communication skills, along with effective interpersonal abilities to influence, drive change, and foster a collaborative, team-oriented culture
• Proven excellence in problem-solving and critical thinking, with flexibility and creativity to address the challenges of a dynamic, growing organization
• Skilled in managing multiple projects simultaneously, effectively prioritizing and adapting to aggressive timelines and shifting priorities
• Position requires up to 20% 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 $160,000-$185,000 / year. 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. Apply tot his job Apply To this Job