Microbiologist

  • location: Libertyville, IL
  • type: Permanent
  • salary: $75,000 - $110,000 per year

job description

Microbiologist

QC Microbiology Supervisor

Responsibilities:

  • Supervision of all QC Micro laboratory testing.
  • Sustain environmental monitoring program
  • Management and optimization of the Aseptic gowning training and qualification program.
  • Management of QC Microbiology training program.
  • Work with QC raw materials team to establish specifications and testing process of raw materials.
  • SME on investigations of sterility failures and environmental excursions.
  • Monitor and trend data
  • Assemble reports on findings from environmental monitoring of cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary.
  • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
  • Develop, revise and review SOPs, qualification/validation protocols and reports.
  • Conduct investigations regarding out of specifications (OOS) results and address and manage non-conformances related to micro procedures.
  • Provide updates at daily and weekly meetings.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Other duties as assigned.
  • NOTE: Shift may include weekends and second shift hours.
Qualifications:

  • Bachelor's degree or advanced degree in Microbiology or related discipline.
  • Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
  • A minimum of 5 years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required. A minimum of 1 year experience supervising/managing/leading microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry.
  • The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell/gene therapy product.
  • Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes.
  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift up to 25 lbs.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, cGMPs, microbiological method development and validation.
  • Strong data integrity knowledge and practices.
  • Identifying, writing, evaluating and closing OOS investigations.
  • Strong knowledge of aseptic manufacturing and EM processes.
  • Equipment and utility IQ/OQ/PQ/PV.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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