QA Microbiology Specialist - Drug Product

The QA Microbiology department is hiring! The QA Microbiology Specialist - Drug Product assists in the planning, coordinating, and facilitating of activities required to maintain sterility assurance throughout the commercialization of Regeneron’s drug candidates. This position supports facility start-up and operations of a new internal aseptic drug product facility and may provide floor support during aseptic filling operations, review process data, and provide guidance for related microbiological investigations.

Preferred experiences for working on Drug Product projects:

• Aseptic formulation and Drug Product filling experience.
• Project Management/Facility Start-up and New Product Introduction (NPI) experience.
• Knowledge of Clean Utilities Systems and monitoring approaches as it pertains to microbial control.
• Familiarization with Annex 1, FDA Guidance for Industry, and other drug product regulatory guidance.
• Familiarization with Quality Risk Management Tools, including but not limited too – Hazard Analysis and Critical Control Points (HACCPs), Layers of Protection Analysis (LOPAs), and Failure Modes and Effects Analysis (FMEAs).
• Develop processes and procedures to support the manufacturing of sterile drug product, such as knowledge in sterility sampling and testing, single-use redundant filtration (SURF), and good isolator operating practices.
• Supports program development for Aseptic Qualification, Aseptic Process Simulation, and Cleanroom Behaviors as it relates to microbial and sterility control in Drug Product Processing.

As a QA Microbiology Specialist, 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.
• 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.
• Support of Deviations, Change Controls and CAPAs, including active participation in investigation, evaluation, and problem resolution.
• Competency to support the development and delivery of training material to inter- and intradepartmental groups.
• Knowledge and background to review and assess Contract Manufacturing Organization deviations as it pertains to microbial control.
• Review and approve partner, raw material, component, and other change notifications as it pertains to microbial control.
• Traveling internationally and/or domestically on occasion.

To be considered for this role you must hold a Bachelor’s degree in the Microbiology, Life Science, or related field and

• 0-2 years relevant experience in the pharmaceutical/biotechnology or related industry for an Associate Specialist
• 2+ years relevant experience in the pharmaceutical/biotechnology or related industry for a Specialist
• 5+ years relevant experience in the pharmaceutical/biotechnology or related industry for a Senior Specialist
• May substitute related experience for education requirement
• Level is determined based on qualifications relevant to the role
• Must be able to enter and work in aseptic controlled environments

#REGNQA #LI-Hybrid

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)

$55,700.00 - $141,900.00