Apogee Therapeutics
Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.
Immunology & Inflammation
51 - 200
Associate Director - GMP Quality Assurance
2 days ago
🏡 Remote – New York
Apogee Therapeutics
Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.
Immunology & Inflammation
51 - 200
Description
• We are seeking a dynamic and results-driven Associate Director of GMP Quality Assurance (QA) to join our team. • This key role will play a pivotal role in ensuring the quality, safety, and compliance of our biologics manufacturing processes. • 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. • The position will report to and partner closely with the Head of GMP QA.
Requirements
• A Bachelor's degree in a relevant scientific discipline or equivalent is required. • Advanced degree is a plus. • 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. • Auditing of GMP facilities is desired. • 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 aggressive timelines and changing priorities. • Ability and willingness to travel up to 20% per year including all company meetings.
Benefits
• 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. • Flexible PTO. • Two, one-week company-wide shutdowns each year. • 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.
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