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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Oversees the laboratory quality control testing of in-process, stability, and final drug products.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Coordinates with members of Manufacturing, R & D, and Formulation to provide analytical support.
- Supervises QC Analysts, distributes work load, and monitors progress.
- Supervises and performs product testing.
- Reviews test reports.
- Ensures QC Analysts receive proper training.
- Attends meetings to keep informed of manufacturing priorities.
- Ensures that safety standards are maintained.
- Ensures compliance with applicable cGMP regulations and SOPs.
- Investigates atypical test results as necessary.
- Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.
- Creates monthly testing reports.
- Completes monthly cGMP compliance inspection report.
- Responsible for all Safety and cGMP activities of associates working in Quality Control Second Shift including Chemistry, Sample Management, Biochemistry, and Microbiology
The person selected for this position will manage a team of 6 to 10 Quality Control Associates dedicated to Wet Chemistry testing and Sample Management activities on the second shift. Clear communication with manufacturing is essential.
Analytical techniques on second shift include but are not limited to:
- UV Protein Concentration
- Density Determination
- Moisture Content
- Total Organic Carbon
- Hiac Royco Particle Size
- Malvern Particle Size
- Micro Flow Imaging Particle Size
- Instron Physical Testing
- High Performance Liquid Chromatography
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 and 2 years supervisory/leadership experience.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls, lift or move objects up to 10 pounds, sit, stand, walk, talk, see, and hear. The employee is frequently required to reach with hands and arms and occasionally required to crouch, smell, and lift or move up to 35 pounds.
Must be able to wear personal protective and/or safety equipment as needed.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate and occasionally loud. The employee is frequently exposed to work near moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The employee is occasionally exposed to extreme cold (non-weather) and risk of electrical shock.
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 recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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