Microbiology Supervisor (Wednesday-Sunday, Second Shift)

Dormont Manufacturing Co; Nouvelle-Calédonie; Sur place; EUR 75 420 - 100 560; Plein temps

Résumé du poste

Dormont Manufacturing Co is seeking a Microbiology Laboratory Manager to oversee testing and support for a contract biotech facility and process development. You will manage environmental monitoring, clean utility testing, and product testing while ensuring rigorous documentation and GMP practices.

The role is onsite full-time with a focus on hands-on laboratory work and staff development in a regulated environment.

Qualifications

• Bachelor degree with several years of technical management experience.
• Master or Doctorate in Microbiology with relevant experience preferred.
• Knowledge of GMPs and biotechnology product regulations.

Responsabilités

• Plan and execute routine Microbial Laboratory work; assist testing when required.
• Employee management and development.
• Makes observations and intermediate data analyses.
• Trainer for the Quality Microbiology team and conducts staff training.
• Maintain strong documentation and technical writing; troubleshoot programs.
• Ensure verifications and qualification protocols are performed appropriately.

Connaissances

Quality orientation

Customer service

Team building

Collaboration

Integrity

Formation

Bachelor of Science in scientific discipline

Master's degree in Microbiology

Doctorate in Microbiology

Description du poste

Please Note: This position is for Wednesday - Sunday, 12pm - 8pm

Position Summary

Responsible for overseeing the testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. Responsibilities include laboratory support, program testing, reporting of results, development and execution of protocols and reports. This person is responsible for the aspects of the following programs as directed by management:

• Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable)
• Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates)
• Compressed Gas Monitoring (Collection, Air Viable, Total Air Particulate, Dragger Tests and specific ID tests)
• Product Testing (Bioburden, Endotoxin, Host Purity, or Non-Host)
• Media Release
• Laboratory Support

It is the expectation that this position is required to be onsite full time. Additionally, this position should be in the laboratory/facility for a minimum of 40% time daily.

Additional Responsibilities

• Plan and execute routine Microbial Laboratory work. Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals. May perform testing when required.
• Employee management and development.
• Makes detailed observations and carries out intermediate data analysis.
• Qualified trainer for the Quality Microbiology team and performs training for staff on programs as needed.
• Strong documentation and technical writing skills.
• Strong understanding of monitoring programs and methods and conducts troubleshooting analysis.
• Knowledge of current regulations and scientific literature.
• Ensures method verifications and qualification protocols and investigations are performed appropriately. May execute testing when required.
• Maintains current state of training prior to execution of tasks.
• Strong working knowledge of sampling equipment and testing instruments.
• Ensures proper labeling, handling, and storage of all chemical and biohazards used in the laboratory. Ensures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures and attends all required safety and health training, including handling hazardous waste.

Minimum Requirements

Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 4–5 years of technical management experience; or a master’s degree with 3 years or a Doctorate degree in Microbiology study and 1 year related experience and/or equivalent training preferred. This person will have 0+ years of managerial experience. Must have knowledge of GMPs and biotechnology‑derived product regulations and be able to react to change productively and handle other essential tasks as assigned.

• Strong orientation for Quality and Customer Service
• Demonstrated level of respect for individuals
• Demonstrated contribution to science in appropriate area
• High level of integrity and personal responsibility
• Strong Collaboration and Team building skills

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.