Compliance Specialist (Drug Product Manufacturing)

Location
Rensselaer, New York, US
Posted
Jul 13, 2018
Ref
13673BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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.

Summary: The Compliance Specialist, Drug Product Manufacturing is a member of the Drug Product Manufacturing Team and is responsible for operations support and compliance related activities for the manufacture of Regeneron products.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Lead and manage deviation investigations, CAPAs, and change controls.

• Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.

• Responsible for generating and tracking performance metrics.

• Maintains knowledge of current good manufacturing practices cGMPs.

• Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.

• Travel to contract manufacturers or business partners, as required (25% or less)

• Maintain required training status on Regeneron specific work instructions and SOP's.

• Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.

• Continuous Process Improvement Implementation.

• May require supervisory responsibilities.

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.

• 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; minimum of BS/BA in scientific discipline with 0-2 years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).

• Specialist; minimum of BS/BA in scientific discipline with 2+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).

• Senior Specialist; minimum of BS/BA in scientific discipline with 5+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).

*Level will be determined based on skills and related experience.*

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.

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