MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
The responsibilities of this position include performing and overseeing quality assurance activities that support all QA aspects of the drug substance release process for clinical and future commercial batches.. The incumbent in this role will review, evaluate and approve all GMP data supporting various MacroGenics programs. As the lead, the incumbent will oversee the timely review and release of the GMP batches manufactured in MacroGenics commercial facility, and will communicate with members of quality assurance and quality control regarding any concerns impacting lot release upon data review. The incumbent will also ensure that quality systems supporting batch release are compliant with internal procedures and regulations.
Responsibilities and Job Duties:
Education & Credentials
Knowledge, Skills and Abilities
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email email@example.com or call (301) 354-3566 and/or 711 for TTD/TTY service.
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