Lead Microbiologist – GMP Quality & Method Validation

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 80,000 - 85,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Yearly bonus eligibility

Job summary

Nivagen Pharmaceuticals Inc in Sacramento, CA is seeking a Microbiologist to ensure pharmaceutical products meet quality standards during manufacturing through real-time monitoring, testing, and documentation in a GMP environment.

The role involves developing and validating microbiology methods, maintaining detailed records, and collaborating with cross-functional teams to drive improvements. This position also includes mentoring staff and contributing to training efforts.

Qualifications

• Bachelor’s degree in microbiology, biology, or related field required.
• Minimum 3 years in a microbiology laboratory.
• Experience in pharmaceutical or compounding environment preferred.
• Experience with United States Pharmacopeia (USP) and regulatory requirements (FDA and cGMP) preferred.
• Experience with microbiological method development and method validation procedures (Sterility, Endotoxin, PET, etc.) preferred.

Responsibilities

• Conducts microbiological testing of primary packaging materials, raw materials, in-process samples, finished products, and environmental samples.
• Develops and validates microbiological test methods in accordance with regulatory requirements.
• Maintains accurate records and prepares reports, protocols, and SOPs.
• Ensures compliance with cGMP and company policies; participates in audits as needed.
• Mentors microbiology staff and provides training and development.
• Identifies opportunities for process improvements and implements best practices.

Skills

Microbiology testing knowledge

Education

Bachelor’s degree in microbiology/biology

Master’s degree preferred

Job description

Nivagen Pharmaceuticals Inc in Sacramento, CA is seeking a Microbiologist to ensure pharmaceutical products meet quality standards during manufacturing through real-time monitoring, testing, and documentation in a GMP environment.

The role involves developing and validating microbiology methods, maintaining detailed records, and collaborating with cross-functional teams to drive improvements. This position also includes mentoring staff and contributing to training efforts.