Job Description

Job Description

Job Responsibilities:

• Build, lead, and support a diverse team of microbiologists responsible for executing a full range of microbiological testing in a GMP environment.
• Deliver effective training, development, and oversight to ensure laboratory personnel maintain strong technical skills and operate in full compliance with internal procedures and regulatory expectations.
• Provide scientific leadership at the bench level to maintain high quality and technical standards within the QC lab.
• Design and implement a robust environmental monitoring (EM) program, along with laboratory workflows to support testing for sterility, endotoxin, bioburden, and other microbiological assays relevant to pharmaceutical products, raw materials, and manufacturing processes.
• Serve as a cross-functional liaison to coordinate laboratory activities—including sampling, testing, instrumentation, and staffing—aligned with operational timelines and client expectations.
• Promote a safety-first culture by clearly communicating safety expectations, reinforcing safe behaviors, and intervening proactively when needed.
• Maintain continuous inspection-readiness for internal audits and regulatory inspections. Serve as a primary contact for auditors, demonstrating compliance with cGMPs, cGLPs, and global regulatory guidelines.
• Lead laboratory investigations, utilizing root cause analysis tools to identify issues and implement timely corrective actions for deviations such as OOS or OOT results.
• Manage the full lifecycle of laboratory documentation and records using electronic and paper-based systems (e.g., QMS, LIMS), including authorship, review, approval, and archival.
• Apply statistical analysis and trend evaluation techniques to microbiology data to drive process improvements and reduce variability.
• Monitor evolving regulatory guidance and industry trends. Leverage continuing education, professional networks, and relevant publications to ensure laboratory practices remain aligned with industry best practices.
• Oversee the qualification, calibration, and maintenance of laboratory instruments and controlled environments. Collaborate with validation and metrology teams to support IQ/OQ/PQ protocols.

Qualifications:

• Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related scientific field.
• At least 5 years of experience in the biopharmaceutical industry, including a minimum of 2 years focused on microbiological testing in a GMP aseptic manufacturing setting.
• Strong working knowledge of global regulatory requirements (FDA, EMA, etc.) relevant to microbiological quality control, including participation in audits or inspections.
• Experience in USP/EP microbiology testing and suitability studies.
• Proficient in laboratory equipment validation and qualification procedures.
• Demonstrated ability to manage electronic lab systems such as LIMS and data analysis tools (e.g., JMP, Minitab).

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