The company vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

The Supervisor, QC Microbiology organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of workflow, test performance, and quality compliance.

Essential Functions and Responsibilities

Investigate and document non-confirming events and environmental excursions.

Troubleshoot and recommend process improvements to achieve greater efficiency ad meet quality goals.

Interact with other the EM/Microbiology departments on a regularly scheduled basis to discuss and harmonize best practices, procedures, and processes between the sites.

Participate in department and cross-functional meetings.

Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department.

Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.

Author and revise Standard Operating Procedures, Work Instructions, Forms, and Protocols to reflect current practices.

Perform microbiological and environmental monitoring data review. Compile and issue quarterly and annual Environmental Monitoring trending reports.

Provide staff development through feedback aimed towards performance development and review.

Qualifications

BS in Microbiology or relevant field required.

Biotechnology Certificate and/or cGMP experience

Minimum of 3 years of experience with environmental monitoring or within the biopharmaceutical industry.

Strong knowledge of microbiological test methods, philosophies, method validation, and method transfer.

Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.

Proficient with computer software with MS Office, Excel, and MODA.

Competencies/Candidate Profile

Adapts to changing business needs, conditions and works with a variety of situations, individuals, groups, and varying client needs.

Ability to remain focused and effective in high-stress situations.

Builds constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect.

Able to handle challenging interpersonal relationships.

Supervisory Responsibility

Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles:

QC Microbiology Associate