Manager QA Microbiology (Drug Substance)

We are currently looking to fill a Manager, QA Microbiology position. This position is responsible for the contamination control strategy for API/drug substance manufacturing facilities, ensuring compliance with regulatory requirements and industry standards.

In this role, a typical day might include the following:

• Resolve problems, identify trends and determine system improvements.

• Provide quality assurance support and oversight. This includes observing and training aseptic operators, and instructing operators in real-time on appropriate behavior; observations shall occur during manufacturing operations.

• Perform audits of aseptic practices including but not limited to aseptic manipulations in ISO-5 environments, general cleanroom behavior, gowning, and cleaning.

• Interpret microbiological data to identify issues that require investigation.

• Provide quality support of API manufacturing with the focus on comprehensive review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.

• Assess and approve the impact of deviation investigations and changes and ensure that all appropriate records are detailed and retrievable.

• Provide SME support for aseptic controls related investigations including support the design and implementation of effective corrective and preventative actions to prevent future recurrence.

• Responsible for review and approval of EM and UM program trending reports.

• Serves as QA document approver for processes/programs in the Facilities, Validation and Engineering spaces and responsible for identifying risks, communicating gaps, and driving mitigations and process improvements to address.

• Participate in process improvement initiatives, performing gap analysis and risk communication.

• Reviewer and/or approver of SOPs and Work Instructions as assigned.

• Act as a trusted advisor to the site by providing compliance advice through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner.

• Maintain consistency of IOPS Microbial programs and initiatives across multiple sites through procedures and facility education of personnel.

• Aid in quality audits of CMOs as the microbiology authority.

• Scheduling coordination, allocation, and alignment of personnel in order to successfully complete project assignments.

• Assess internal findings and communicate updates, metrics and outstanding items to senior personnel.

• Be responsible for the daily prioritization and scheduling of process area walk-throughs and other support functions.

• Lead a team of microbiology professionals, providing mentorship, training, and support as needed.

This role may be for you if you:

• Demonstrate interest in facilitating group or project team endeavors and building team unity, ability to effectively communicate and influence the outcomes of the decision-making process, ability to work independently to provide QA support for large, multifaceted projects

• Possess an understanding of technical and operational aspects of late phase to commercial GMP aseptically processed drug substance and sterile-filtered drug product manufacturing regulations and excellent written and verbal communication skills.

• Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.

• Are able to enter and work in environmentally classified areas (cleanrooms).

• Have experience interpreting and applying standards and regulations to microbiological and sterility assurance control programs for the purposes of interpreting data, implementing procedures, and remediation projects.

• Understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in an API/drug substance manufacturing environment.

• Possess relevant experience as a Microbiologist in one or more of the following areas: Environmental Monitoring, Clean Utilities Monitoring, Bacterial Endotoxin Testing, Bioburden/Microbial Enumeration Testing, Sterility Testing, Mycoplasmas Testing

To be considered for this role you must hold a Bachelors degree in Life Sciences or related field with the following minimum amounts of experience in pharmaceutical or biologics manufacturing environment for each level:

• Associate Manager 6+ years

• Manager 7+ years

• Sr Manager 8+ years

May substitute proven 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 step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)