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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Manages all aspects of clinical and commercial parenteral drug product planning, including assuring domestic and international regulatory compliance, and oversee drug product contract manufacturers as needed.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Support Associate Director of Supply Chain Operations, as needed
• Maintain product integrity and company reputation by ensuring that commercial and clinical drug product manufacturing comply with cGMP and other applicable international guidelines.
• Maintain external schedule at contractors to meet company commercial and clinical goals.
• Maintain internal Drug Substance scheduling for all process areas
• Manage commercial and clinical drug product manufacturing, including all scheduling to meet company requirements; maintain appropriate metrics and information.
• Review and approve all critical documentation, such as tech transfer reports, validation master plans, etc. related to clinical and commercial drug product manufacturing at contractors and business partners.
• Oversee the management of internal and/or external toxicological drug product production including all scheduling to meet the company requirements.
• Oversee, review, and/or participate in audits of current or potential contract manufacturer and business partner drug product manufacturing facilities.
• Keeps knowledge current with regulatory requirements/changes, and industry trends and advises management on needed actions; recommends changes to manufacturing procedures for regulatory compliance.
• Interact with regulatory agencies on defined matters.
• Develop, organize and maintain external drug product manufacturing database of schedules, contractor documentation, RFQs, specifications, quotes, batch records, validation information, etc. for ease of retrieval by internal and inter-departments.
• Travel to external partner sites as business needs require.
Education and Experience:
• Requires BS/BA in a scientific discipline with 5+ years of related experience in a cGMP environment; Biopharmaceutical Supply Chain experience a plus; MS/MBA preferred.
• Management and/or leadership experience required.
• Travel required to external business partners (approximately 25%).
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 recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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