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

Experience with Quality Management System Regulations is a plus

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

Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators

Strong communication (oral and written), and effective interpersonal skills with the ability to influence and drive change

Excellent problem-solving and critical thinking abilities

Flexible and creative to meet the needs and challenges of a growing, dynamic company

Focus on fostering a culture of collaboration and teamwork

Ability to manage multiple projects with fast timelines and changing priorities

Position requires up to 20% travel including mandatory in-person attendance at All Hands meetings typically held twice per year

The anticipated salary range for candidates for this role will be $210,000-$235,000. 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.

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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.