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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The External Manufacturing Specialist oversees all aspects of drug product contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance.
Level to be determined based on qualifications relevant to the role
Essential Duties and Responsibilities include, but are not limited to, the following:
Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.
Coordinates DP manufacturing activities at contract and/or business partner sites, including but not limited to: scheduling of all batches, supply of materials, providing direction on shipment of bulk or finished product, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities, and enlisting support from others who will provide any required associated reports and technical expertise.
Liaison between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
Leads a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
Supports all investigations which concern external manufacturing and associated shipping operations.
Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers and business partners.
Performs reviews of pre-production master batch records and executed batch records.
Ability to travel up to 25% (domestic and international).
Knowledge, skills, and abilities:
Knowledge of drug product manufacturing from formulation through the final package.
Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
Strong interpersonal, written and oral communication skills.
Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
Gains understanding from provided instructions and works towards goals with minimal supervision.
Exhibits a degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
Shows resiliency and flexibility in the face of challenges and adversarial situations.
Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.
Experience in collaborating with CMOs/CROs is preferred.
Fluent in English with a preference given to candidates with competencies in German and/or French (oral and written).
Education and Experience:
Associate Specialist: BS/BA in scientific discipline with 0-2 years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).
Specialist: BS/BA in scientific discipline with 2+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).
Senior Specialist: BS/BA in scientific discipline with 5+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).
Relevant experience may be considered in lieu of education.
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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.