QC Micro Lab Operations Specialist

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