QC Microbiology Scientist (Biotechnology)

Location: Middletown, Delaware, United States; on-site

Company

hirify.global supports pharmaceutical and biotechnology manufacturing and quality control operations.

What you will do

• Perform and review advanced microbiological QC testing for drug products, raw materials, packaging components, and utilities.
• Lead environmental monitoring, bioburden, endotoxin, microbial limits, microbial identification, and sterility testing.
• Troubleshoot technical issues, lead investigations, and resolve deviations, OOS results, and atypical findings.
• Author, review, and revise SOPs, test methods, technical reports, and other laboratory documentation.
• Participate in method transfers, qualifications, validations, stability studies, and equipment activities.
• Train and mentor QC Analysts and Associates and support client and regulatory audits.

Requirements

• Bachelor’s degree in Microbiology, Biology, or a related scientific discipline with 5+ years of QC microbiology experience in a GMP-regulated pharmaceutical or biotechnology environment; alternatively, a master’s degree with 3+ years or a PhD with 1+ years of relevant experience.
• Deep expertise in environmental monitoring, sterility, endotoxin, and bioburden testing and related microbiological instrumentation.
• Ability to lead investigations, author technical reports, and resolve complex technical issues.
• Strong knowledge of GMP regulations, USP <61>, <62>, <85>, <1116>, ICH guidelines, and data integrity principles.
• Ability to work on-site in Middletown, Delaware.

Nice to have

• Experience with LIMS, Empower, or other electronic laboratory systems.
• Previous experience in a CDMO or multi-client environment.
• Experience providing technical training and mentorship.
• Strong communication skills and experience supporting audits and regulatory inspections.

Culture & Benefits

• Work in a GMP-regulated pharmaceutical and biotechnology manufacturing environment.
• Support startup and steady-state operations, product release, stability studies, validation, and regulatory audits.
• Maintain complete, accurate, and inspection-ready laboratory documentation.
• Follow cGMP, safety, corporate quality, and regulatory standards.