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 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. You will support our mission to develop and deliver differentiated biologic therapies to patients in need.

Key Responsibilities

• Assist QA Leadership with development and execution of planned QA audit schedules supporting GMP activities
• Partner with Technical Operations with selection and ultimate oversight of drug substance / drug product contract development manufacturing organizations (CDMOs) in support of Phase 3 and process performance qualification (PPQ) activities
• Independently performs assigned GMP audits
• Partner effectively with Technical Operations and provide quality guidance in GMP data and documentation generated
• Verify manufacturing and testing activities adhere to GMP regulations and guidelines and ensure a culture of continuous improvement
• Timely management of batch record review and release to ensure continuous supply for clinical trials, and to guarantee the consistent production of high-quality products
• Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards
• Provide QA support of device development activities (pre-filled syringes, autoinjectors, etc.)
• Maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and quality events
• Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures
• Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization
• Assist in establishing and reporting key quality metrics to monitor performance and drive improvements in GMP compliance and product quality
• Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness
• Ensure employees are adequately trained in GMP requirements and quality procedures
• Maintain comprehensive and accurate records and reports related to quality assurance activities
• Foster a culture of quality within the organization, emphasizing the importance of compliance, data integrity, and patient safety
• Assist in GMP inspection readiness activities to support regulatory authority inspections

Ideal Candidate

• A bachelor’s degree in relevant scientific discipline or equivalent is required, advanced degree a plus
• A minimum of 10 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in auditing and the manufacture of monoclonal antibodies or biologics
• Experience with CDMO oversight, including partnering and aligning on quality issues
• Experien