Job Summary:
Responsible for directing and overseeing microbiological programs and methods activities for processes, instruments and equipment. Ensures the effective use of material, equipment and personnel while developing products and processes at high quality levels.
- 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
Job Responsibilities:
- Strong understanding of monitoring programs and methods, makes detailed observations and conducts troubleshooting analysis.
- Strong technical knowledge of programs. Makes detailed observations and carries out advanced data analysis.
- Execute and review routine Microbial Laboratory work. Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals. May perform testing when required. 10% Strong documentation and technical writing skills.
- Familiarity with 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.
- 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.
- Full responsibility for the direction of all assigned microbiological monitoring and testing activities at the site.
- Lead, assess, coach and develop departmental associates. Manage performance; ensure team meets company, site and personal expectations and meets objectives; guide the professional growth of team. 1
- Develop and monitor performance criteria so as to allow measurement and continuous improvement of efficiency and quality, thereby ensuring meeting of committed targets on-time and error-free performance.
- Strong documentation, technical writing. Responsible for Trending and Characterization reports. Ensures Quality Metrics are Maintained. (Training, Deviations, CAPAs, LIRs, ALNs)
- Strong understanding of regulations and industry expectations. Support regulatory and client audits. 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.
Job Requirements:
- Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 13 – 15 years of technical management experience; or a master’s degree with 11 – 14 years or a Doctorate degree in Microbiology study and 9 –12 years related experience and/or equivalent training preferred.
- Minimum of 5 years’ managerial experience.
- This position should be in the laboratory at a minimum of 1 hour a day, 3 time per week.
Requires a demonstrated track record in the following areas:
- Attainment of aggressive growth and profit objectives
- 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
- Record of Innovation
- Strong Collaboration and Team building skills
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
Top Skills
What We Do
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.
With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs.
KBI is proud to be a JSR Life Sciences Company.
