Project Manager QA Microbiology

Rensselaer, New York
Apr 04, 2018
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: Responsible for planning, coordinating and facilitating microbial control activities required for the development and commercialization of Regeneron's drug candidates.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Resolve problems, identify trends and determine system improvements.
• Ability to foster working relationships between multiple Regeneron departmental representatives. Must maintain current knowledge in microbiological practices and methods as they relate to industry and Regeneron expectations;
• Implement change when necessary within the guidelines of GMP.
• Support the review of microbial control related documents, including but not limited to, SOPs, Validation and Qualification documentation, Study Protocols, and Investigations.
• Maintain project timelines associated with department initiatives to support the evolving business.
• Support logistics associated with regulatory inspections.
• Attend meetings relevant to assigned projects as needed.
• Track internal findings and communicate updates, metrics and outstanding items to senior personnel when necessary.
• Project support may span into operations, validation and inspection management.
• Maintain consistency of IOPS Microbial programs and initiatives across multiple sites through procedures and facility education of personnel.
• Aid in quality audits of CMOs as the microbiology expert, providing feedback and aid in generation of audit reports.
Education and Experience:
• Requires BS/BA degree in Life Sciences or related field and 8 years of relevant experience, preferably in the pharmaceutical or biotechnology industries. Level to be commiserates with experience.
• Relevant experience may be considered in lieu of educational requirement.
• Must be able to enter and work in aseptic controlled environments.

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.

Requisition Number: 12922BR