Associate Director, QA Microbiology

Location
Rensselaer, New York, US
Posted
Oct 06, 2018
Ref
14462BR
Required Education
Masters Degree/MBA
Position Type
Full time
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: Position focuses on supporting the improvement of practices and procedures that ensure the effectiveness of the IOPS' Contamination and Microbial control programs. This position will also assess, justify and support the implementation of new technologies to help support product safety. In addition, this position will support the goal of zero regulatory observations by partnering with the Inspection Management Team (IMT) with inspection preparations and regulatory inspections. This position will report into the Chief Microbiologist for Regeneron's Industrial Operations and Product Supply (IOPS) organization.

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

• Responsible for improving upon and maintaining the general facility bioburden program and remediation efforts where necessary;

• Lead investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plans determination and remediation plans. Work in concert with the director of QC Microbiology to achieve these goals;

• Maintain industry standards with respect to microbial control and mitigation - incorporate any new industry standards/use of new monitoring equipment into the IOPS system.

• Provide input on technology transfer plans related to microbiological method transfers (method validation);

• Develop and provide input on the development and modification of microbial action limits;

• Review and provide input on microbiology SOPs, microbiology assay validation and related documentation;

• Review and provide input on environmental monitoring SOPs and validation;

• Review and provide strategic support to understanding and managing bioburden trend levels. Reports excursions and their interpretation to senior management;

• Responsible for constantly assessing the effectiveness of IOPS sanitization agents;

• Domestic and foreign travel required.
Education and Experience:

• A MS/BS degree in microbiology, medical technology, biology or related field and a minimum of 10 years' experience in the pharmaceutical or biotechnology industry is required. Knowledge and experience in qualifying clean rooms, clean utilities and manufacturing processes is necessary. Experience should also include quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals.

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.