Supervisor, QC Microbiology

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.

The Supervisor, QC Microbiology will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control-microbiological and technical standards. The QC Environmental Monitoring Supervisor will also provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance.

Essential Functions And Responsibilities

Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.

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

Schedules and monitors daily operation of department based on projected client demands.

Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.

Approval of investigations and documentation of non-confirming events and environmental excursions.

Recommends process improvements to achieve greater efficiency within the department and between sites.

Participates in department and cross functional meetings.

Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.

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

Other duties as assigned.

Qualifications

Bachelor’s degree in a Microbiology or relevant field

Minimum of 7+ years of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.

Minimum of 2 years of experience in a supervisory or lead role.

Strong knowledge of FDA and EU regulatory standards. cGMP experience required.

Strong knowledge of microbiological test methods and philosophies.

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

Proficient with computer software with MS Office and LIMS (MODA experience preferred).

Competencies/Candidate Profile

Acts decisively

Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively.

Builds and maintains relationships

Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders.

Communicates effectively

Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback.

Fosters continuous improvement and innovation

Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies.

Fosters integrity and honesty

Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically.

Supervises and manages performance

Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues.

Manages projects and functions

Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs.

Supervisory Responsibility

Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.

Provides oversight and direction to the employees in accordance with the organization's policies and procedures.

Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.

Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback.

Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.

Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.

Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.

Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.

Direct Reports

QC Microbiology Analysts

Quality Requirements

Build Quality into all aspects of your work by maintaining compliance to all quality requirements.

Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).

Attend all required Quality & Compliance training at the specified interval.

Minimum Required Training to be Completed within the First 90 Days of Hire

GxP/GDP Training as assigned

EHS Safety Training

Aseptic Processing Standards

The employee must be able to comply with the company’s personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role.

Working Environment

While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.

Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.

Must have the ability to observe staff in a cleanroom environment for a period of time.

Must be able to work in a team-oriented environment.

Must have the ability to work with specialized equipment.

This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate.

Physical Requirements

The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.

An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects.

Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear.

Must be able to exchange information in person, on the telephone, and to make presentations.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Tuesday- Saturday, 8:30 AM to 5:00 PM