KBI Biopharma
Associate Director, Microbiology
KBI Biopharma, Durham, North Carolina, United States, 27703
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.
Programs Responsibilities:
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.
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.
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.
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 times 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
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Programs Responsibilities:
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.
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.
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.
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 times 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
#J-18808-Ljbffr