Microbiologist

• 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.