Associate Director, QC Microbiology

About the role

Responsible for 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 position is responsible for 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

This position is required to be onsite full time and should be in the laboratory at a minimum of 1 hour a day, 3 times per week.

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.
• 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.
• Assures proper labeling, handling, and storage of all chemical and biohazards used in the laboratory.
• Assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures; attends all required safety and health training, including handling hazardous waste.

Requirements

• 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.
• 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.

Skills

Language Ability

• Ability to read, analyze, and interpret the most complex documents and regulations.
• Ability to respond effectively to the most sensitive inquiries or complaints.
• Ability to write speeches and articles using original or innovative techniques or style.
• Ability to make effective and persuasive speeches and presentations on controversial or complex topics to senior management, peer groups, employee groups, and/or customers.

Reasoning Ability

• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases.
• Ability to deal with a variety of abstract and concrete variables.

Math Ability

• Ability to apply advanced mathematical concepts such as exponents, logarithms, statistical analysis, and permutations.
• Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.