Lead Microbiologist-Personal Care/Pharma - Bowling Green - Kelly Science, Engineering, Technology & Telecom

    Kelly Science, Engineering, Technology & Telecom
    Kelly Science, Engineering, Technology & Telecom Bowling Green

    16 hours ago

    Description

    Lead Microbiologist-Personal Care/Pharma

    All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.

    Location: Greater Toledo, OH

    Position Type: Full-Time | Technical Leadership & Quality Control

    Sign-on Bonus

    Full Benefits

    Work Schedule: Day Shift

    The Lead Microbiologist, Personal Care/Pharma is a pivotal dual-function role, serving as both a primary technical expert and a hands-on contributor. You will balance sophisticated laboratory work with the leadership of a high-performing team, ensuring the safety, quality, and efficacy of a diverse product portfolio—including FDA Over-the-Counter (OTC) drugs, cosmetics.

    Key Responsibilities

    Technical Leadership & Team Management

    • Lead by Example: Actively participate in microbiological testing, including OTC/disinfectant efficacy studies and preservative challenge tests.
    • Mentorship: Supervise and coach analysts, fostering a culture of accountability, continuous learning, and technical excellence.
    • Strategic Oversight: Balance daily lab efficiency with long-term quality goals.

    Quality Control & Regulatory Compliance

    • Audit Readiness: Direct interaction during FDA audits and support for all internal/external regulatory reviews.
    • Validation: Draft and execute microbiological validation protocols and method verification studies.
    • Compliance Standards: Maintain strict adherence to cGMP, GLP, ISO, and USP standards.
    • Documentation: Review data for accuracy, revise SOPs, and conduct weekly data compliance reviews.

    Investigations & Operational Excellence

    • Critical Investigations: Lead root cause analysis, write Out-of-Specification (OOS) reports, and manage CAPAs.
    • Environmental Monitoring: Oversee manufacturing hygiene, cleanroom monitoring, and utility testing.
    • Continuous Improvement: Identify and implement lab process improvements and stay current on global industry trends.

    Core Technical Competencies

    • Aseptic Technique: Mastery of sterility maintenance and contamination monitoring.
    • Microbial Identification: Expertise in dilutions, culture propagation, Gram staining, and colony enumeration.
    • Product Development Support: Hands-on experience with antimicrobial effectiveness and preservative efficacy testing.
    • Culture Maintenance: Management of cryopreserved cultures and preparation of specialized media/reagents.

    Education & Experience Requirements

    • Education: Bachelor's degree in Microbiology, Biology, or a related field (Advanced degree preferred).
    • Professional Experience: 5+ years in QC Microbiology (Pharmaceutical or Cosmetic industries preferred).
    • 5+ years of hands-on experience in a manufacturing environment.
    • Regulatory Mastery: In-depth knowledge of FDA and EPA guidelines.
    • Validation Skills: Proven ability to write and execute validations for microbiological test methods.
    • Physical Capability: Ability to collect samples from manufacturing equipment, raw material containers, and storage tanks. xhmxlyz

    If you qualify for the above position, please submit your resume for consideration.

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    Lead Microbiologist-Personal Care/Pharma

    Kelly Science, Engineering, Technology & Telecom

    Lead Microbiologist-Personal Care/Pharma · Location: Greater Toledo, OH · Position Type: Full-Time | Technical Leadership & Quality Control · Sign-on Bonus · Full Benefits · Work Schedule: Day Shift · The Lead Microbiologist, Personal Care/Pharma is a pivotal dual-function role, ...

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