Top 1 Microbiologist Jobs in Santa Rosa, Ca

Microbiologist
NeilMed Pharmaceuticals —Santa Rosa, CA
- Weekends as needed
- 5 years
- Master's degree
- Analysis skills
- Health insurance
- Dental insurance

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Microbiologist

NeilMed Pharmaceuticals -
Santa Rosa, CA

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Job Details

Full-time

Benefits

Health insurance
Dental insurance
Paid time off
Vision insurance
Life insurance
Retirement plan

Qualifications

Incident investigation techniques for hazard identification
Data integrity assurance
USP standards
Statistics
Production data analysis
Defect resolution root cause analysis
Cleanroom environmental monitoring
Process optimization
Team leadership
Quality control statistical data analysis
Preventive action implementation
Microbiological culture and identification
Continuous improvement (laboratory quality control method)
Technical writing experience within manufacturing
Production deviation management
Good documentation practices (GDP)
Corrective and preventive actions (CAPA)
Cleanroom protocols
Internal investigations
Trend analysis
Quality reports
Manufacturing facility experience
Team development
Laboratory reports
Policy & process development
Professional development support
Bachelor's degree
Quality risk management
Operational risk mitigation
Pharmaceutical company experience

Full Job Description

Category: Biotech

Position: Full Time

Type: Salaried

Location: Santa Rosa CA

COMPANY PROFILE

Ketan C. Mehta, MD and Nina Mehta, founded NeilMed® Pharmaceuticals, Inc. in January 2000 from Dr. Mehta’s medical office and in a short span, we have over 500 employees. NeilMed® is the largest manufacturer and supplier of LVLP (Large Volume Low Pressure) saline nasal irrigation systems in the world.

The NeilMed® brand of products help alleviate common nasal and sinus symptoms in a simple, safe, effective and affordable way. The company supplies millions of products to end users through various trade channels. Our headquarters & manufacturing facility is based in Santa Rosa, California, USA. In addition to our USA headquarters, we also supply and have offices in multiple countries worldwide. Our unique business model has been a very strict vertical integration, for achieving precision and fast execution at all levels. NeilMed® prides itself in being part of the small community of Santa Rosa, located in the heart of Sonoma County’s wine country in Northern California.

Our flagship products are NeilMed® SINUS RINSE™ and NeilMed® NasaFlo® Neti Pot. These products are available in most stores in the USA, Canada, and several other countries around the world. There are currently over 40 different products for nasal and sinus care, and all are OTC (over the counter). With an extremely dedicated small team of loyal, and hard working leadership group, NeilMed® continues to formulate innovative ideas to market. Additional diversification plans include the introduction of surgical devices for hospitals and emergency rooms. NeilMed® supports medical research in several countries and educating health care professionals and consumers. We believe in excellent 24 hour customer service, helping local communities, and donating for natural disasters.

OUR MISSION

The mission of our company is safety and affordability to sustain long-term growth, creating drug free and effective nasal / sinus care products for millions of consumers worldwide.

Job Description

NeilMed (Santa Rosa, CA) takes pride in delivering quality OTC products from development through manufacturing. We’re looking for a Senior Microbiologist to join our team and be the subject-matter expert for microbiological control across our manufacturing, QC and operations functions.
As Senior Microbiologist at NeilMed, you will play a key role in safeguarding product quality, consumer safety and regulatory compliance. Your expertise will help maintain our manufacturing excellence, support innovation and ensure that our OTC products reach consumers reliably and safely.

Job Experience

Skills & Requirements

Lead and execute advanced microbiology testing of raw materials, in-process samples, finished goods, packaging materials, and utilities in support of OTC drug manufacturing.
Drive and oversee the environmental monitoring program (clean-rooms, production areas, utilities) and ensure microbiological integrity of the manufacturing environment.
Investigate microbiological failures and out-of-specification (OOS) results; perform root-cause analysis and lead corrective & preventive actions (CAPA).
Develop/validate microbiological methods (e.g., microbial enumeration, microbial limits, preservative efficacy, endotoxin/bioburden, sterility if applicable) aligned with compendial standards (USP/EP) and regulatory requirements for OTC drugs.
Write and review protocols, reports, deviations, CAPAs, trend analyses, change controls and SOPs relevant to microbiology.
Collaborate closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D and Engineering to create and maintain microbiological control strategies across the product/process.
Monitor and analyze microbial trend data and recommend improvements to facility/processes for risk mitigation and continuous enhancement.
Provide technical leadership and mentorship to junior microbiologists/technicians; promote a culture of excellence, data integrity and continuous improvement.
Support internal audits, external inspections, supplier/contract-lab evaluations as required.
Maintain strict adherence to cGMP, GLP, Good Documentation Practice (GDP), and data integrity standards in the lab and manufacturing environment.

Qualifications

Required:

Bachelor’s degree in Microbiology, Biology or a closely related science (Master’s/PhD preferred).
5–10+ years’ experience in microbiology within a pharmaceutical/OTC drug manufacturing environment (or similarly regulated manufacturing).
Hands-on experience with microbiological methods: bioburden, endotoxin, sterility (if applicable), preservative efficacy, microbial identification, environmental monitoring (air, surfaces, utilities).
Familiarity with 21 CFR 210/211, OTC monographs, FDA inspections, compendial guidelines such as USP <61>, <62>, etc.
Proven experience with method validation, protocol/report writing, deviation/CAPA investigations, trend analysis and root-cause
Strong leadership, communication and interpersonal skills; ability to train and mentor team members and influence cross-functional stakeholders.
Strong organizational skills, meticulous attention to detail, ability to prioritize tasks and meet manufacturing-driven timelines (including some flexibility for after-hours/weekend support).
Proficiency with LIMS and statistical/data review tools; comfort working in a manufacturing laboratory environment with microbiological cultures, incubators, etc.

Preferred:

Experience in vertically-integrated manufacturing operations (raw material

finished goods) and understanding of upstream/downstream impact of microbiology.
Demonstrated track record supporting regulatory inspections or audits (e.g., FDA).
Experience working in an OTC or consumer health product environment.
Strong analytical and problem-solving mindset; ability to influence process improvements based on microbial trend data.
Self-starter attitude and ability to work autonomously within a cross-functional team in a fast-paced manufacturing setting.

Benefits

We offer a competitive benefits package including medical/dental/vision
Retirement plan
Paid time off
Opportunities for professional development
50k Life Insurance Policy (paid by Neilmed)

Apply Now

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