To provide direction and oversight for the QC Microbiology department; manage systems for microbial control of a biologicals manufacturing facility. The position includes responsibility for the facility environmental monitoring program, microbiological testing of raw materials and biopharmaceutical product intermediates. The QC Microbiology Director provides leadership and manages performance of staff and represents site microbial control policies and procedures during interactions with the Health Authorities and supports contract manufacturing and testing sites.
|In conjunction with the Head of Quality Control, shapes the strategic direction of QC Microbiology through ownership and implementation of the cGMP Laboratory principles and system level enhancement.|
Aligns department resources for development, implementation and maintenance of an effective facilities EM program, accountable for QC Microbiology facilities monitoring and microbiological testing, including oversight for contract manufacturing and testing sites.
Participates in preparation of nnual budget requirements.
Provides technical subject matter expertise based on familiarity with current regulatory guidelines on facilities monitoring and microbiological testing, reviews authors applicable sections of regulatory submission, draft responses to questions.
Accountable for policies on microbiological testing and operations of the laboratory. Provides input on hiring decisions, access to resources and training and manages performance and development of staff.
Ensures the laboratory is properly equipped, provide recommendations for instrument acquisition and delegate accountability for ensuring all laboratory systems are appropriately qualified and maintained.
Includes accountability for laboratory performance, establishing effective metrics for monitoring department performance and respond to negative performance trends. Works in conjunctions with Manufacturing to resolve/improe environmental monitoring trends.
Oversees quality systems deployment within the department, develops and execute continuous improvement initiatives within QC Microbiology
Coaches and mentors staff, oversees effective utilization of all quality management systems by laboratory personnel, develop and maintain compliance metrics and report to management
Participates in the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products
Bachelor’s degree and graduate degree (PhD) in Microbiology is strongly preferred.
Minimum of twelve (12) years relevant experience in Microbiology and Quality Control of biological and small molecules.
Minimum of five (5) years of leadership/supervisory experience.
Strong knowledge of cGMP and cGLP regulations, safety and environmental requirements and other related digital quality tools.
Demonstrated expertise with current microbial control of facilites, cleaning sanitation and sanitization of GMP manufacturing and testing areas.
Detailed working knowledge of current standards and procedures for facilities environmental monitoring.
Experience with development, transfer and implementation of microbial method qualification.
Experience with building and sustaining a capable laboratory organization.
Expertise with current guidance and regulatory expectations; proven problem-solving abilities, excellent oral and written communication skills, and strong interpersonal skills are required.