QA Microbiology Specialist (Drug Product Support) at Regeneron Pharmaceuticals, Inc.

The QA Microbiology Specialist - Drug Product Support assists in the planning, coordinating, and facilitating of activities required to maintain sterility assurance throughout the development and commercialization of Regenerons drug candidates. This position may provide floor support during aseptic filling operations, review process data, and provide support for related microbiological investigations.

In this role, a typical day might include:

• Knowledge, education, experience and training in microbiology, aseptic technique, gowning and microbial control, Environmental Monitoring (EM) for controlled environments, as well as microbiological testing such as bioburden and endotoxin.

• Proficiency in technical writing.

• Ability to support the review of microbial control related documents, including but not limited to,

• SOPs, validation and qualification (IQ/OQ/PQ) documents, study protocols, and investigations

• Skills to support departmental project completion including leading cross-functional discussions

• Experience using GMP computer system software to process change controls, technical documents, procedures, work instructions, protocols, perform data trending, create metrics etc.

• Familiarity of regulatory bodies such as Food and Drug Administration (FDA), European Medicines Agency (EMA), Japanese Pharmacopia (JP), etc.

• Competency to support the development and delivery of training material to groups of 5-25 people or more, as required

• Identify continuous improvement opportunities

• Present data related to sterility assurance and microbial control to leadership

• Maintain required training and gowning qualification where required

• Aid in quality audits, lab investigations or any matters related to sterility assurance and microbial control at Regeneron or non-Regeneron facilities

• Traveling internationally and/or domestically on occasion, as required

This role may be for you if you:

• Have knowledge and background to review and assess the appropriateness of manufacturing deviations, and an array of change notifications related to manufacturing processes to assure sterility assurance

• Maintain current knowledge in microbiological practices and methods as they relate to industry and Regeneron expectations

• Are able to cultivate working relationships between multiple Regeneron departmental representatives

• Are able to work independently with support from management

To be considered for this role you must hold a Bachelors degree in the Microbiology, Life Science, or related field and the following amount of relevant experience in the pharmaceutical/biotechnology or related industry for each level:

• Associate QA Microbiology Specialist : 0-2+ years

• QA Microbiology Specialist : 2-5+ years

• Sr QA Microbiology Specialist : 5+ years

Must be able to enter and work in aseptic controlled environments. May substitute related experience for education requirement. Level is determined based on qualifications relevant to the role.

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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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)