Sr. Director QC Microbiology

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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Looking for a charismatic leader with strong critical and strategic thinking skills to oversee the QC microbiology department. This role will provide microbiology support to cell-culture, manufacturing, and facilities departments. Ensure QC department metrics and cycle times are monitored and achieved. Experience with EMEA, ISO, FDA, and USP guidelines and regulations regarding Environmental Monitoring and Utility Systems (compressed gas, clean steam, WFI, HVAC).

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

• Lead, manage and professionally develop microbiology laboratory staff

• Oversee daily operations & address lab needs

• Manage Environmental Monitoring and testing schedule, progress, data, and work quality; provide continuous improvement ideas

• Conduct trouble-shooting and OOS investigations

• Direct the efforts and study design for qualifying new utility systems and classified areas

• Assist Manufacturing and Facilities teams to solve microbiology related deviations/issues

• Maintain project timeliness (i.e. implementation of new equipment, methods, room/utility PQs, etc.)

• Assist in creation, implementation, and administration of Microbiology based programs (training, gowning, etc.);

• Represent QC during regulatory inspections to respond and address microbiology issues and solutions.

Knowledge, Skills and Abilities include, but are not limited to:

• Strong microbiology lab operation management skills;

• Strong analytical and investigational skills;

• Solid GMP compliance and inspection experience;

• In depth knowledge of pharmaceutical microbiology, including endotoxin testing and bioburden testing.

• Experience in environmental control and monitoring of clean rooms and utilities;

• Experience with data review, trending, and limit setting;

• Technical writing experience including SOPs, investigations, and validations;

• Knowledge of Pharmaceutical Water systems and HVAC systems;

• Basic knowledge of sterilization science;

• General knowledge of biotech process, equipment and their microbiological control.

Education and Experience:
Requires a Bachelor's degree, Ph.D. preferred, in microbiology or closely related field. Strong leadership skills and 15 years of progressive microbiology laboratory management experience in a pharmaceutical or biotech industry.
Level to be determined based on 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, disability status, protected veteran status, or any other characteristic protected by law.