Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: This individual will direct the departmental operations functions in the CMC Regulatory Sciences (CMC RS) Department. These functions include but are not limited to Product Specifications, Document Quality, and Coordination within the CMC RS Department.
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
* Oversees the development and maintenance of product quality specifications to support program and business needs.
* Supports the review of CMC content for accuracy, clarity, consistency, and conformance to writing conventions.
* Promotes high writing standards within CMC RS and throughout IOPS through copy editing of CMC content and administration of the technical writing training program.
* Supports the coordination of all efforts within the CMC RS Department including department metrics, program timelines, and coordination of activities with other departments and external functions to ensure CMC content can be finalized to meet program and business needs.
* Keeps management and all stakeholders informed of decisions, overall strategy, and project status.
* Identifies project issues and contributes to the development of alternative CMC Regulatory Sciences strategies.
* Manages and develops staff and direct reports.
* BS/BA required (advanced degree preferred,) in Chemistry, Biology or related field with a strong background in CMC related activities. 10+ years of related experience, preferably in a biotech or pharmaceutical cGMP environment including significant experience in CMC related activities.
* Leadership and/or managerial experience required.
* Experience in managing quality systems and program management is considered a plus.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.