Sr. Microbiologist

Summary: Responsible for QC microbiological aspects of cGMP compliance and testing.

Level to be determined based on qualifications relevant to the role.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Responsible for QC aseptic processing aspects of cGMP compliance and testing related to drug product
• Perform microbiological studies to support qualification of isolators, fill finish lines and clean room environments
• Perform microbiological validations for sterile drug products
• Assist drug product personnel in the identification of microbiological root cause analysis and provide technical advice, as needed
• Participate in the investigations related to drug product, review of alert and action limit investigations and implement corrective action, as needed
• Participate in sterilization process validation activities involving microbiology, as needed
• Participate in the investigation of microbiological product OOS results and DNF, as needed
• Contribute to the preparation of technical proposals, amendments, reports and memoranda
• Contribute toward creating and revising microbiological SOPs
• Assist in the review of qualification reports related to drug product

Knowledge, Skills & Abilities
• Ability to lift-up to 25 pounds
• Ability to stand and walk for extended periods of time
• 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 interpret data and develop improvement plan
• Initiating the development of leadership skills by providing training and guidance to others
• Anticipates and plans for change
• Critical thinking skills
• Demonstrates analytical skills through problem-solving
• Demonstrates leadership by being approachable
• Participates in projects in addition to daily responsibilities

Education and Experience
• Requires BS/BA in Microbiology, Biochemistry, Chemistry, Biology or related field with 5+ years of relevant experience, preferably with experience in the pharmaceutical or biotechnology industries.
• Experience with sterile manufacturing, pharmaceutical documentation practices and demonstrated leadership skills required.

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.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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