Director, QC Microbiology

3 weeks ago

Gaithersburg, United States Selecta Biosciences Full time

Summary

The Director of QC Microbiology oversees the execution of the microbiology program supporting lot release and environmental monitoring for Cartesian. They will have proven leadership skills and success working well in a team environment as they will be tasked with building out the QC Microbiology team.

Principal Duties/Responsibilities:

* Oversight and execution of microbiology program supporting lot release and environmental monitoring for Cartesian. Opportunity to build the QC Microbiology team
* Principle QC liaison with site manufacturing operations teams with respect to microbiological routine testing and support
* Recruitment, development, and management of the Microbiology labs
* Budget management of capital and operational costs for the QC Microbiology teams
* Managment and oversight of the day-to-day operations of the microbiology laboratory, including sample processing, data analysis, and reporting.
* Developing and implementing innovative technologies, methods, and processes for microbial analysis
* Ensuring that all laboratory activities are conducted in compliance with relevant regulations and guidelines
* Providing scientific leadership and technical expertise to the laboratory team
* Managing and mentoring a team of microbiologists and technicians, including hiring, training, and performance evaluation
* Collaborating with other departments and external partners to support applicable projects
* Oversight of the maintenance and calibration of laboratory equipment and instrumentation
* Preparing reports and presentations for senior management and external stakeholders
* Ensuring that the QC Microbiology Team operates in compliance with company policies and directives, evolving Health Authority regulations and expectations
* Supporting the QC planning and scheduling activities as required

Qualifications:

* The successful candidate must hold a Ph.D. with post-graduate experience in Microbiology specifically and a minimum of 10 years' experience working on Microbiology focused projects in the Pharmaceutical Industry.
* Deep and demonstrated understanding and experience of the principles of GMP
* An accomplished team leader of large teams with the ability to motivate and develop departmental staff through effective feedback and coaching
* The candidate will have proven success working well in a team environment, as well as proven leadership skills to manage a team of professionals through changing business needs.
* Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture
* Experience with technical transfer of new products and product changeover is essential, as well as experience interacting with regulatory agencies.
* Must have extensive management experience of increasing responsibility.
* Experience in building and growing an organization is desired
* Extensive knowledge of US and EMA GMP regulations and guidance.
* Demonstrated leadership, interpersonal, communication, and motivation skills.
* Demonstrated understanding of test methods and instrumentation associated with the testing of biopharmaceutical processes including microbiological release testing
* Excellent written and verbal communication skills, with the ability to present complex scientific information to a variety of audiences
* Planning and organizing skills are required to plan, execute, and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment.

Work Environment:

The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.

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