Manufacturing Production Support Specialist (Clean Room Controls)

Job Description

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.
*This is a 1st shift, Monday-Friday position
Summary: This position will report into Manufacturing to provide leadership and direction for clean room contamination control in support all manufacturing programs; including, but not limited to the manufacturing process and associated clean utilities, qualification and validation activity, microbial sampling/testing practices, data trending, and investigations. Oversees the Manufacturing microbial control for commercial manufacturing production in addition to implementation of improvements. The level will be determined based on education and experience.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Ensures that all manufacturing clean room controls are in compliance with cGMP guidelines and applicable regulations
• Reviews and provides feedback on area procedures, including SOP’s, master batch documentation, change controls, and validation protocols/reports in accordance with cGMP standards
• Chairs reoccurring and ad-hoc cross functional teams in support of manufacturing microbial control initiatives
• Documents and investigates quality events associated with contamination control of commercial manufacturing to ensure effective root-cause analysis, corrective action plans determination, product impact, and remediation.
• May develop and deliver microbial control training
• Prepares reports and metrics by collecting, analyzing, and summarizing information and trends
• Makes decisions; develops and implements policies
• Implements preventive and corrective actions to enhance clean room controls
• Participates in regulatory inspections and any required follow up actions
• Ability to foster working relationships between multiple departments of Regeneron in support of bulk manufacturing microbial control efforts
Education and Experience:
• Bachelors degree in Microbiology, Medical Technology, Biology or related field and 5+ years of relevant cGMP manufacturing experience.
• Knowledge and experience in pharmaceutical microbiology, cell culture manufacturing, clean utilities, clean room design and operations, and microbial sampling and testing techniques.
• Senior Specialist requires Bachelors degree in Microbiology, Medical Technology, Biology or related field and 5+ years of relevant cGMP manufacturing experience.
• Principal Specialist requires Bachelors degree in Microbiology, Medical Technology, Biology or related field and 8+ years of relevant cGMP manufacturing experience.
Knowledge, Skills, & Abilities:
• Ability to maintain integrity and honesty at all times
• Ability to work independently or as part of a team
• Ability to communicate with transparency
• Continuously drive to improve processes for improved performance
• Demonstrate respectful behavior at all times
• Ability to multi-task
• Ability to analyze and identify trends
• Develops and delivers effective presentations
• Problem-solving skills
• Ability to train others on basic systems and processes
• Strong written communication
• Ability to work in an ever-changing environment
• Critical thinking skills
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.