At Minaris Regenerative Medicine our 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.
This position is responsible for the oversight and supervision of the QC Microbiology team at the 4 Pearl Court Minaris Allendale Facility. In this role, this person will be responsible for management of the Microbiology program at the facility, for completion of quarterly and annual environmental monitoring report, data reviews and approvals and external laboratory management. Supports in-house microbiology testing. Supervises QC Microbiology Supervisors. Provides cross departmental support, as well as, collaborates with other departments to support organizational and functional strategy. Develops and/or revises policies and procedures in support of operational excellence initiatives. Represents Microbiology in internal and external audits which may include interaction with regulatory health authorities and clients.
Essential Functions And Responsibilities
Functions as the site Microbiology partner, in collaboration with other stakeholders, ensuring microbiology standards are enforced.
Coordinates the investigation and closure of deviations with effective root cause analysis.
Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented and monitored and effectiveness checks are completed.
Approves documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc.
Approves and delivers quarterly and annual environmental monitoring reports; Develops continuous improvement plans or actionable deliverables. Participates in the execution of quality system improvement programs and initiatives.
Perform monthly environmental data review.
Manage electronic MODA system.
Support insourcing projects and validations to meet timelines and ensure compliance.
Establishes Microbiology KPI Reporting and Metrics.
Establishes and maintains relevant process controls and data feedback systems to monitor the operation of the department.
Participates in internal audits, regulatory agencies, and client audits.
Other duties as assigned
Bachelor of Science in biological sciences or other relevant field of study.
10-12 years' relevant microbiology experience in cGMP biotech and/or pharmaceutical environments. Experience in both clinical and commercial manufacturing is preferred.
Proficient in FDA and EMEA regulations and a working knowledge of root cause analysis.
Understanding of quality system applications, including the training, deviations, CAPA management, etc.
Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)
Experience in organizing and leading teams.
Experience participating in health authority inspections and/or client audits.
Highly organized and capable of successfully managing multiple priorities using effective time management techniques
Proven ability to maintain accurate recordkeeping records
Written and oral communication skills in English; facilitate effective presentations
Must be accountable for work product and have a strong work ethic.
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:
Directly supervises 10 employees within the Microbiology department(s).
Indirectly supervises 20 employees within the Microbiology department(s).
Minimum Required Training (optional)
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
Must have the ability to work with specialized equipment
Must be able to handle the standard/moderate noise of the manufacturing facility
Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
Must be able to utilize proper personal protective equipment (PPE) to handle human specimens, gases, corrosive chemicals, etc.
Must be able to type utilizing computer based systems
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Monday-Friday, 1st Shift