This job is posted on behalf of Step Up Recruiting by Top Echelon.

Job Description

Responsible for providing technical oversight of the Microbiology Laboratory, including Endotoxin, Bioburden, Microbial Identification (Micro IDs), and other laboratory assays. Serves as the functional lead on the laboratory bench, performing data review, approval, and other activities to support daily laboratory operations.

ESSENTIAL DUTIES AND ROLE RESPONSIBILITIES

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• Provide technical expertise and perform QC Microbiology activities, ensuring full compliance with cGMP, GDP, and applicable global regulations and standards, including FDA, USP, EP, ICH, EU Annex 1, DEA, and OSHA requirements.
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• Perform data review and approval as needed to support day-to-day laboratory operations.
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• Author, review, approve, and maintain high-quality SOPs, protocols, specifications, impact assessments, validation reports, and technical documentation, ensuring alignment with current regulatory expectations and consistent application across sites.
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• Lead, review, and oversee microbiological out-of-specification (OOS) and deviation investigations, ensuring timely execution, sound scientific rationale, thorough root cause analysis, and effective, sustainable corrective and preventive actions (CAPAs).
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• Strengthen investigation capabilities by promoting risk-based thinking, data-driven analysis, and defensible conclusions to support continuous improvement in investigation quality and cycle time.
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• Provide training and mentorship to junior-level employees.
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• Lead and support strategic initiatives to improve laboratory efficiency, leveraging microbiological data to inform risk-based decision-making for aseptic processing, facility controls, and manufacturing practices.
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• Identify, develop, and manage projects supporting new laboratory capabilities, technology implementations, and drug development or lifecycle programs, ensuring alignment with business priorities, regulatory expectations, and future manufacturing needs.
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REQUIRED SKILLS AND EXPERIENCE

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• Bachelor's degree (BS) in Microbiology, Biology, Biochemistry, or a related scientific discipline.
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• Minimum of 7 years of experience in pharmaceutical or biotechnology quality laboratories.
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• Knowledge of cGMP and global regulatory requirements, including USP, EP, ICH, and EU Annex 1, with the ability to translate regulatory expectations into practical, compliant laboratory and environmental monitoring (EM) practices.
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• Experience in the development, validation, verification, and transfer of microbiological and environmental monitoring methods, ensuring regulatory compliance and consistent implementation across sites.
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• Excellent communication, organizational, and technical writing skills, with the ability to produce and review clear, concise, and inspection-ready documentation.
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PREFERRED QUALIFICATIONS

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• Experience supporting both development and commercial manufacturing environments.
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• Prior experience in a contract development and manufacturing organization (CDMO), multi-product facility, and/or biologics manufacturing facility.
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• Prior experience using a MODA system.
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