OVERVIEW:

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 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 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

Minimum Required Training

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.
• 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.
• Must have ability to work in a team-oriented environment and with vendors.
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
• Must have the ability to work in the cleanroom environment for extended period of time
• Must have the ability to work with specialized equipment
• Must be able to handle the standard/moderate noise of the manufacturing facility

ASEPTIC PROCESSING STANDARDS:

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

Physical Requirements

•  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.
• The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance)
• Heavy cryo-gloves must be used when working with liquid nitrogen

Direct reports:

QC Microbiology Associates