POSITION TITLE: Microbiology Manager
REPORT TO: Director of Quality
Under general supervision, perform various microbiological related activities for a cGMP compliant Fill/Finish operation applying standard practices, techniques and procedures. Able to supervise all Microbiologists and Environmental Monitoring (EM) Technicians, review and approve reports, records, etc., Other responsibilities include monitoring, troubleshooting, maintaining and validation of equipment required or related to environmental monitoring operations including support systems, as applicable.
- Manages the Microbiology laboratory operation, ensuring laboratory processes provide high quality analytical support for manufacturing, engineering and validation operations while ensuring compliance of protocols, GMPs, and safety regulations.
- Provides broad-based QC Microbiology expertise and counsel to and on behalf of the organization.
- Provides leadership, management, and training and career coaching for Micro Laboratory staff.
- Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
- Provide guidance and expertise on performing Sterility testing and Isolator.
- Review and approve Bioburden, B&F, and Sterility testing reports.
- Prepare daily, weekly and Monthly Environmental Monitoring schedule.
- Review Environmental Monitoring data generated in GMP manufacturing Facility.
- Provide technical support with regards to EM issues in manufacturing.
- Oversee the qualification and training of EM technicians.
- Oversee and supports EM related investigations with regards to GMP operation.
- Oversee and manage the contract laboratories handling EM related work for Pyramid.
- Support media fill activities at Pyramid Laboratories.
- Oversee Gowning Qualification program at Pyramid Laboratories.
- Support /conduct training with regards aseptic techniques and EM related issues.
- Support client Audits of Pyramid Laboratories by providing an overview of EM program.
- Provide forecast for equipment and material use to fully support EM function and future expansions.
- Support Regulatory audits of Pyramid Laboratories by responding to relevant questions regarding the EM function.
- Performs other related duties and responsibilities as assigned.
- BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Pharmacy or related science and minimum of 6-8 years of related experience.
- Experience in a cGMP environment with a strong working knowledge of a variety of quality systems.
- Aseptic and sterile manufacturing experience strongly preferred: CAPA and root cause expertise, internal audit, and experience in a QC microbiology laboratory in the pharmaceutical or biotech industry also preferred.
- Experience with Microbiology and Environmental Monitoring is a must.
- Experience in an aseptic environment a must.
- Prior people management experience is preferred.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .