Nivagen Pharmaceuticals, Inc. · 2 months ago
Microbiologist
Sacramento, CA
Full-time
Onsite
Mid Level
$70K/yr - $80K/yr
3+ years expNivagen Pharmaceuticals, Inc. is a global company focused on enhancing lives by developing cost-effective generic drugs. As a Microbiologist, you will ensure that pharmaceutical products meet quality standards during manufacturing through testing, documentation, and compliance with regulatory requirements.
ManufacturingMarket ResearchPharmaceutical
Responsibilities
Conducts microbiological testing of primary packaging materials, raw materials, in process sample, finished products, and environmental samples using various techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing
Develops and validates microbiological test methods in accordance with compendial and regulatory requirements
Maintains accurate and detailed records of all microbiological testing and analysis performed. Prepares and reviews reports, protocols, and SOPs related to microbiological activities
Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures. Participate in internal and external audits as needed
Microbiology-related projects, including method transfers, validations, and investigations
Collaborates with cross-functional teams to achieve project objectives and timelines
Provides training and mentorship to microbiology staff
Shares knowledge and expertise to promote continuous learning and development within the microbiology team
Identifies opportunities for process improvements and optimization within the microbiology laboratory
Implements best practices and innovative solutions to enhance efficiency and effectiveness
Performs a variety of Microbiology testing to assess the strength, identity, and purity of test samples and/or materials
Performs other duties as assigned
Qualification
Required
Bachelor's degree in microbiology, Biology, or related field required
Minimum of 3 years of experience in a microbiology laboratory required
Strong knowledge of microbiological testing techniques, methods, and equipment
Conducts microbiological testing of primary packaging materials, raw materials, in process sample, finished products, and environmental samples using various techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing
Develops and validates microbiological test methods in accordance with compendial and regulatory requirements
Maintains accurate and detailed records of all microbiological testing and analysis performed
Prepares and reviews reports, protocols, and SOPs related to microbiological activities
Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures
Participate in internal and external audits as needed
Microbiology-related projects, including method transfers, validations, and investigations
Collaborates with cross-functional teams to achieve project objectives and timelines
Provides training and mentorship to microbiology staff
Shares knowledge and expertise to promote continuous learning and development within the microbiology team
Identifies opportunities for process improvements and optimization within the microbiology laboratory
Implements best practices and innovative solutions to enhance efficiency and effectiveness
Performs a variety of Microbiology testing to assess the strength, identity, and purity of test samples and/or materials
Performs other duties as assigned
Preferred
Master's degree preferred
Previous experience in a pharmaceutical or compounding environment preferred
Experience with compendia testing: United States Pharmacopeia, and regulatory requirements (Food and Drug Administration and cGMP) preferred
Experience with microbiological method development and method validation procedures like Sterility Testing, Endotoxin Testing, Disinfectant Efficacy Study, Water Testing, Method Validation, Environment Monitoring, Microbial Limit Testing, PET, and microbiological hold time validation, container closure integrity
Benefits
Yearly bonus eligibility
Medical, dental and vision coverage
Paid time off plan
401k savings plan
Company
Nivagen Pharmaceuticals, Inc.
Nivagen is engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market.
11-50 employees
H1B Sponsorship
Nivagen Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (19)
2023 (15)
2022 (5)
2021 (11)
2020 (7)
Funding
Current Stage
Early StageTotal Funding
$31MKey Investors
Telegraph Hill Partners
2026-01-06Acquired
2023-08-09Series Unknown· $5M
2020-05-19Series Unknown· $16M
Recent News
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-07
2025-05-23
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