Job Description

Rx Group is recruiting for a clinical stage cell therapy biotech, based in Maryland, who are searching for a Director, QC Microbiology, overseeing the microbiology program supporting lot release and environmental monitoring. Demonstrating adept leadership and collaborative skills, they will spearhead the expansion of the QC Microbiology team.

Principal Duties/Responsibilities:

• Lead and oversee the microbiology program supporting lot release and environmental monitoring.
• Drive the growth of the QC Microbiology team.
• Serve as the principal QC liaison with site manufacturing operations teams for microbiological routine testing and support.
• Responsible for recruiting, developing, and managing the Microbiology labs.
• Manage budgets for capital and operational costs of the QC Microbiology teams.
• Provide hands-on management and supervision of daily operations in the microbiology laboratory, including sample processing, data analysis, and reporting.
• Introduce and implement innovative technologies, methods, and processes for microbial analysis.
• Ensure all laboratory activities comply with relevant regulations and guidelines.
• Offer scientific leadership and technical expertise to the laboratory team.
• Mentor and manage a team of microbiologists and technicians, including recruitment, training, and performance evaluation.
• Collaborate with other departments and external partners on applicable projects.
• Oversee maintenance and calibration of laboratory equipment and instrumentation.
• Prepare reports and presentations for senior management and external stakeholders.
• Ensure compliance with company policies, evolving Health Authority regulations, and expectations for the QC Microbiology Team.
• Support QC planning and scheduling activities as necessary.

Qualifications:

• Hold a Ph.D. with post-graduate experience in Microbiology, along with a minimum of 10 years' experience in Microbiology-focused projects within the Pharmaceutical Industry.
• Possess a deep understanding and experience of GMP principles.
• Exhibit strong leadership skills in motivating and developing departmental staff.
• Proven success in team environments and adeptness in managing professionals through evolving business needs.
• Ability to influence cross-functional work in a matrix environment, from startup to commercial manufacture.
• Experience in technical transfer of new products and product changeover, including interactions with regulatory agencies.
• Extensive management experience of increasing responsibility.
• Desired experience in building and growing organizations.
• Comprehensive knowledge of US and EMA GMP regulations and guidance.
• Proficiency in leadership, interpersonal, communication, and motivation skills.
• Understanding of test methods and instrumentation associated with biopharmaceutical processes, including microbiological release testing.
• Excellent written and verbal communication skills for conveying complex scientific information.
• Strong planning and organizing abilities to manage resources against timelines and project commitments, adapting to changing priorities and dynamic work environments.

Please contact Hemish Ilangaratne at h.ilangaratne@rx-group.io or apply directly via the website for further information.