NeilMed Pharmaceuticals
Contract Recruiter and HR Operations (NeilMed Pharmaceutical), Freelance Prompt Engineer
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.
Responsibilities
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 lifecycle.
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, etc.
Proven experience with method validation, protocol/report writing, deviation/CAPA investigations, trend analysis and root‑cause resolution.
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 Skills
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.
Pay range and compensation package
We offer a competitive benefits package including medical/dental/vision.
Paid time off.
Opportunities for professional development.
50k Life Insurance Policy (paid by Neilmed).
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Manufacturing, Project Management, and Management
Industries Pharmaceutical Manufacturing
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Responsibilities
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 lifecycle.
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, etc.
Proven experience with method validation, protocol/report writing, deviation/CAPA investigations, trend analysis and root‑cause resolution.
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 Skills
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.
Pay range and compensation package
We offer a competitive benefits package including medical/dental/vision.
Paid time off.
Opportunities for professional development.
50k Life Insurance Policy (paid by Neilmed).
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Manufacturing, Project Management, and Management
Industries Pharmaceutical Manufacturing
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