Lead Microbiologist-Personal Care​/Pharma

Lead Microbiologist-Personal Care/Pharma

Position Type: Full-Time | Technical Leadership & Quality Control

The Lead
Microbiologist
, Personal Care/Pharma is a pivotal dual-function role, serving as both a primary technical expert and a hands-on contributor. You will balance sophisticated laboratory work with the leadership of a high-performing team, ensuring the safety, quality, and efficacy of a diverse product portfolio—including FDA Over-the-Counter (OTC) drugs, cosmetics.

• Lead by Example: Actively participate in microbiological testing, including OTC/disinfectant efficacy studies and preservative challenge tests.
• Mentorship: Supervise and coach analysts, fostering a culture of accountability, continuous learning, and technical excellence.
• Strategic Oversight: Balance daily lab efficiency with long-term quality goals.

• Audit Readiness: Direct interaction during FDA audits and support for all internal/external regulatory reviews.
• Validation: Draft and execute microbiological validation protocols and method verification studies.
• Compliance Standards: Maintain strict adherence to cGMP, GLP, ISO, and USP standards.
• Documentation: Review data for accuracy, revise SOPs, and conduct weekly data compliance reviews.

• Critical Investigations: Lead root cause analysis, write Out-of-Specification (OOS) reports, and manage CAPAs
  .
• Environmental Monitoring: Oversee manufacturing hygiene, cleanroom monitoring, and utility testing.
• Continuous Improvement: Identify and implement lab process improvements and stay current on global industry trends.

• Aseptic Technique: Mastery of sterility maintenance and contamination monitoring.
• Microbial Identification: Expertise in dilutions, culture propagation, Gram staining, and colony enumeration.
• Product Development Support: Hands-on experience with antimicrobial effectiveness and preservative efficacy testing.
• Culture Maintenance: Management of cryopreserved cultures and preparation of specialized media/reagents.

• Education: Bachelor’s degree in Microbiology, Biology, or a related field (Advanced degree preferred).
• Professional
  
  Experience:
  
  5+ years in QC Microbiology (Pharmaceutical or Cosmetic industries preferred).
• 5+ years of hands‑on experience in a manufacturing environment.
• Regulatory Mastery: In‑depth knowledge of FDA and EPA guidelines.
• Validation
  
  Skills:
  
  Proven ability to write and execute validations for microbiological test methods.
• Physical Capability: Ability to collect samples from manufacturing equipment, raw material containers, and storage tanks.

If you qualify for the above position, please submit your resume for consideration.