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 Regulatory Affairs CMC Manager/Senior Manager will provide regulatory guidance to ensure development activities, manufacturing, and testing for all MacroGenics products are compliant with the relevant regulations, guidelines and industry standards. Responsibilities include collecting, reviewing and assembling CMC-related submission documentation, and ensuring appropriate review and approval of submissions prior to submitting to a Regulatory Authority.
Responsibilities and Job Duties
Bachelor’s degree in a scientific discipline
Regulatory Affairs CMC Manager
Sr. Regulatory Affairs CMC Manager
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 firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service.
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