Supervisor QC Microbiology

Location
Rensselaer, New York, US
Posted
Sep 14, 2018
Ref
13991BR
Required Education
Bachelors Degree
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: Supervise the QC Microbiology Operations group

2nd shift, 12:00 pm- 8:30 pm, Mon-Fri

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

• Coordinates and reviews validation testing at the IOPS Facility and Contract Manufacturers/Fillers.

• Ensures department metrics and cycle times are monitored and achieved .

• Oversees daily operation of Microbiology Validation Laboratory this includes: Bioburden and Endotoxin testing of validation samples such as In-Process, Release Drug Substance and Raw Materials for Bioburden and Endotoxin testing, this also includes oversite of sterility validation and routine testing.

• Validation of compendia methodologies and interpretation of raw data.

• Supports internal and regulatory audits.

• Ensures contract manufacturers and fillers are adhering to internal policies and standard compendia guidelines.

• Supports Manufacturing Microbial Investigations.

• Writes and revises SOPs, methods, protocols, and reports.

• Ensure testing is performed accurately and in compliance with cGMP procedures, established regulatory requirements, SOPs, and other approved test methods.

• Perform Lab investigations as needed. Implement corrective actions as applicable.

Knowledge, Skills, and Abilities:

• Ability to motivate employees and build team morale.

• Strong leader and teacher.

• Ability to identify problems and escalate accordingly.

• Ability to provide feedback and career counseling.

• Ability to communicate with transparency.

• Continuously drive to improve processes for improved performance.

• Coordinate, organize and assign daily activities of operations.

• Support employees, executing against established guidelines and common procedures and policies.

• Ability to effectively manage high-stress situations.

• Demonstrated flexibility during ambiguous situations.

Education and Experience:

• Requires BS/BA in Life Sciences or related field with 5+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry. 1- 3 years of supervisory experience preferred.

Level to be determined based upon 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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