QC Micro Lab Operations Specialist - Regeneron Pharmaceuticals, Inc.

Regeneron is currently looking for a QC Lab Operations Specialist to join our QC (Quality Control) Microbiology Operations Team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The QC Microbiology team performs microbiological assays, related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation. This position will specialize in supporting the team through project management, technical support and compliance related activities for Fill/Finish.

As a QC Lab Operations Specialist, a typical day might include the following:

• Serves as a QC Microbiology representative on cross-functional teams to facilitate advancements of projects which includes but not limited to continuous improvements for testing and sampling processes and microbiological methods.

• Applies a fundamental understanding of the science behind the microbiological assays to perform advanced troubleshooting and complete complex microbiological investigations.

• Collaborates with team members on activities associated with Change Control. This includes initiation, impact and implementation of the change; also the initiation and closure of workflows and CAPAs.

• Participates in the writing of technical documents and studies to troubleshoot and support investigations.

• Applies their expertise in the creation and update of SOPs.

• Leads data gathering and analysis in support of investigations and business decision making.

• Leads the evaluation of data entry, analysis, and reporting of microbiological data and support implementation of changes in order to identify streamlining opportunities.

• Participates in internal audit discussions and seeks alignment with the team to address microbial requests.

• Collaborates in technical discussions and problem solving with outside entities (i.e. contract manufacturers and contract test labs) to drive resolutions.

• Seeks support to make good judgements and quick decisions regarding microbiological methods.

• Assists in the integration of technical updates into the team procedures while maintaining compliance with regulatory agencies.

• Implements the creation and review of LIMS configurations to meet the needs of QC Microbiology, this may include implementation of new specifications, design of LIMS/ELN templates for new/revised test methods, design of queries and reports.

This role might be for you if you:

• Have advance Knowledge in Microbiological Test Methods (This includes, but is not limited to: Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants.

• Enjoy working in a fast-paced environment and you have the innate ability to balance multiple priorities and/or prioritize and execute them.

• Can take on new and sometimes ambiguous challenges and learn quickly.

• Assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy.

• Are able to work in a team environment and demonstrate respectful behavior at all times to promote and encourage a learning environment.

• Can develop and drive scientific and/or business-related improvement ideas.

• Have working knowledge of Microsoft Suite applications (Word, Excel, Powerpoint), Laboratory Information Management System (LIMS), Deviation Management Systems, and Learning Management Systems.

To be considered for the QC Micro Lab Operations Specialist you must be able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Life Sciences, microbiology or biology preferred; or equivalent combination of education and experience. For various levels you must have the following:

• Assoc QC Lab Operations Specialist: 0-2 years of relevant experience

• QC Lab Operations Specialist: 2+ years of relevant experience

• Sr QC Lab Operations Specialist: 5+ years of relevant experience

Level is determined based on qualifications relevant to the role.

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)