Job Description

Be better. Live better. That's our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives The Supervisor, Microbiology, is responsible for supervising the Microbiology Laboratory, providing technical expertise, leadership, and training to the Microbiology team. The Supervisor, Microbiology applies technical skills in the training of the micro team members operations/process flow, prioritization, instrumentation, and troubleshooting, as well as in assessing new methodologies and procedures for method transfer. Providing quality laboratory results in a timely, accurate and efficient manner to ensure high-quality and safe products are produced for our customers. Creating a support environment that values success, supporting others in learning, promoting continuous improvement and preventing errors. The Supervisor, Microbiology reports to the Manager, Microbiology and Sterility Assurance.

RESPONSIBILITIES:

Responsible for prioritizing workload for laboratory analysts, schedule testing according to performance expectations, ensuring test sample results are reported in a timely manner to meet the customer requirements, as well as internal and external communication. Responsible for Microbiology Laboratory personnel training, evaluation, and approval of training records. Provide leadership and coaching to team members and identify training needs and development where required as well as participate in the assessment, hiring, and interviewing of Microbiology staff. Responsible for objective setting, managing performance, task allocation, training in microbiology laboratory procedures and contributing to audit readiness. Responsible for overseeing the operations of the microbiology laboratory, scheduling testing and overtime to meet production and shipping schedules. Responsible for microbiology analyst's annual reviews. Acts as the Biosafety Officer for the CL-2 laboratory and maintains Public Health Agency of Canada requirements, training and license for CL-2 lab. Perform timely and effective Microbiology Laboratory Investigations (MLIR) for test results that are out-of-specification. Responsible to provide laboratory support for Sterility Assurance investigations. Responsible for the non-aseptic environmental monitoring program sampling and results. Responsible for the water system test results, read out, and annual trend reports. Responsible for notifying the Manager, Microbiology and Sterility Assurance of all non-conformance events that occur in the water system, NAPA and APA test results. Responsible for microbiology lab test results that include but are not limited to: Microbial Enumeration Test, GPT, MPT, water system test results, AET, antibiotic assays, biological spore assays and microorganism identification. Ensure excellent documentation controls, and capabilities are in place to maintain data integrity, and ensure timely and effective actions are taken. Participate and support customers and regulatory audits as a SME in Microbiology. Participate in internal audits, as well as maintaining and updating relevant microbiology laboratory SOPs. Review product specifications and test methods to current USP and customer requirements and propose appropriate updates. Assist Technical Services Team in Microbiological Validation studies by reviewing, providing technical expertise, and executing activities as required including data analysis and preparing reports. Identify areas for improvement and improve laboratory efficiency.

QUALIFICATIONS:

B.Sc. in Microbiology is preferred. A B.Sc. in a related field will be considered with the appropriate experience. Minimum 5 years of hands-on experience working in a microbiology laboratory in a GMP facility and a CL-2 lab. Excellent planning, teamwork, organizational, interpersonal and communication skills (both written and verbal) Knowledge of microbiology laboratory techniques, identification systems (Biolog), equipment, and materials. Knowledge of computerized information systems, such as LIMS. Working knowledge of GMP, GLP, PHAC, HPFBI guidelines and safety guidelines. Knowledge in aseptic processing is an asset. Demonstrated problem solving skills with focus on Right First Time. Project leadership skills are an asset.
Job Type: Full-time

Work Location: In person