Sr. Director QC Microbiology
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Rensselaer, NY
- Start date
- Nov 11, 2019
View more
- Discipline
- Quality, Quality Control, Science/R&D
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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