QC Microbiology Scientist

Role Summary

QC Microbiology Scientist at Regeneron. Specializes in microbiology test methods to support cell-culture, manufacturing (drug substance and drug product), and facilities; ensures regulatory compliance and drives continuous improvements in microbiological methods.

Responsibilities

• Perform Test Method validations, studies, and assist with troubleshooting efforts (Investigations).
• Participate in building processes where gaps have been identified.
• Participate in tasks associated with aseptic process simulations.
• Assist with Change Control activities, including initiation, impact assessment, implementation, workflow and CAPA closures.
• Assist with writing technical documents and studies to troubleshoot and support investigations.
• Assist with creation and update of SOPs.
• Capture data for analysis in support of investigations and business decision making.
• Evaluate data entry, analysis, and reporting of microbiological data; support implementation of changes to identify streamlining opportunities.
• Seek and evaluate alternative solutions; translate ambiguity into actionable steps; provide effective problem solving.
• Assist in internal audit discussions and address microbial requests with the team.
• Assist with technical discussions and problem solving with outside entities (e.g., contract manufacturers and contract test labs) to drive resolutions.
• Communicate technical solutions effectively within the organization.
• Participate in integrating technical updates into team procedures while maintaining regulatory compliance.
• Assist in the creation and review of LIMS configurations to meet QC-Microbiology needs, including specifications, templates, queries, and reports.
• Suggest incorporation of new items into reference libraries for microbiological methods.

Qualifications

• 2+ years of relevant experience for the QC Microbiology Scientist role; 5+ years for Sr. QC Microbiology Scientist (level determined by qualifications).

Skills

• Knowledge of microbiological test methods (Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) related to Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities, and Disinfectants.
• Excellent written, verbal, and interpersonal communication; ability to interact with all levels inside and outside the company.
• Strong organizational and time management skills; ability to prioritize multiple priorities.
• Proficiency in IOPS systems (e.g., BMRAM, Discoverant, Documentation Compliance, LIMS, MS Word, MS Excel, Process Compliance).

Education

• BS/BA in Life sciences; microbiology or biology preferred.

Additional Requirements

• Monday-Friday, 8am-4:30pm work schedule.