Key Responsibilities:
- Oversee daily operations of the Microbiology laboratory, ensuring smooth and efficient workflow.
- Lead strategic planning efforts for the laboratory and its staff to meet organizational goals.
- Serve as the subject matter expert on contamination control and microbiological testing of parenteral drug products.
- Participate in customer and regulatory audits, ensuring compliance with industry standards.
- Engage with new clients and manage client interactions related to microbiological services.
- Attend site metrics meetings to discuss laboratory performance and key performance indicators (KPIs).
- Contribute to site-wide improvement projects to enhance laboratory efficiency and effectiveness.
- Manage laboratory budgeting, ensuring proper allocation of resources and cost control.
- Review and interpret data, including protocols, investigations, and lab documentation, to ensure accuracy and compliance.
- Oversee the entire laboratory team, providing leadership, guidance, and direction.
- Conduct staff performance reviews, handle disciplinary actions, and ensure team members receive appropriate training and development.
- Work independently with limited supervision while also collaborating on cross-functional teams.
- Writes and revises Microbiology and other relevant SOP's, as required
- Manage staff shift schedules to ensure adequate manufacturing support.
- Expert in CGMP guidelines, ISO 17025, and USP microbiological testing, including USP <51>, <61>, <62>, <71>, <85>, and <1116>.
- Maintain and update laboratory policy and procedure manuals, assist in developing and validating procedures, and ensure proper documentation.
- Ensure timely completion of projects, CAPAs, and investigations.
- Review and approve environmental and microbiological test results, including those from contract labs, to support lot disposition and site priorities.
- Oversee the review and implementation of compliance guidelines, customer projects (e.g., Method Transfer, Development), validation, and continuous improvement efforts to meet or exceed industry standards.
- Lead cross-departmental collaboration to improve Contamination Control Strategy and Environmental Monitoring Program.
- Represent the department in regulatory, customer, and internal audits.
- Address audit observations and execute related CAPAs in a timely manner.
- Develop and execute training on laboratory methods, instrumentation, and aseptic technique.
- Build and maintain the department's Training Matrix to align with industry standards and continuous improvement goals.
Key Qualification
- Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Minimum Six (6+) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
- Must have experience working in a cGMP environment and aseptic facility.
- Minimum of Two (2) years of leadership experience.
- Extensive EMPQ knowledge and experience within EMPQ protocols is a must.
- Microbiological testing experience including method transfers and qualifications.
