Microbiology Assistant Scientist - FL0011443810

Ology Bioservices, Inc.
Job Description
Reference #: 3712173

Description
The Assistant Scientist performs Microbiology department related testing according to USP methods and established procedures that follows cGMP guidelines and demonstrates high proficiency level on the task assigned.

Specific tasks include but, are not limited to: Understand, perform and demonstrate proficiency level in the following areas of microbiological analysis: In-process and finished product samples to include: bioburden, bacterial endotoxin and sterility .Raw material testing for specific microbial requirements.
  • Routinely gown and maintain certification for all classified/controlled manufacturing areas.
  • Keep and maintain cGMP certification.
  • Perform and maintain initial and annual gowning qualifications for all departments in facility.
  • Environmental Monitoring of cleanrooms and dynamic processes including: viable air sampling, surface sampling, non-viable air sampling, and personnel monitoring.
  • Sampling and analysis of purified water, Water for injection and clean steam.
  • Sampling and analysis of compressed gases and air.
  • Biological indicator receipt, issuance, and analysis.
  • Media fill inspection
  • Growth promotion of media and media fill units.
  • Perform microbial identifications, evaluating and interpreting results to identify objectionable organisms from environmental monitoring and product testing.
  • Demonstrate the ability to understand and interpret test results and use the results to make a decision with regard to acceptance of the associated criteria and requirements.
  • Conduct laboratory deviation investigations developing CAPA's for non-conformances/excursions
  • Perform data entry and utilize trend reports to identify adverse trends.
  • Identifying and purchasing the necessary supplies needed to support laboratory needs.
  • Training other employees on tasks as an SME or trainer.
  • Perform testing in BSL-2/BSL-3 laboratories.
  • Administrative function for laboratory software.
  • Lead and mentor other laboratory team members.
  • Serve as a technical reviewer of departmental operating procedures and be able to write the standard operating procedure, protocol, and reports as required
  • Other duties as assigned.
Position Requirements
  • 4-year degree in Microbiology or related field from an accredited agency.1-4 years experience in a cGMP QC Microbiology laboratory.
  • Strong verbal/written and interpersonal communication skills.
  • Team player willing to work in an environment where individual initiative, collaboration, and accountability are valued.
  • Ability to work independently with minimal supervision.
  • Adjustments in education/experience will alter Assistant/Associate/ and Scientist
Number of Openings1

EOE Statement
About the Organization
Thank you for your interest in joining the Ology Bio-services team! We believe we have the most talented and committed employees in the industry with decades of combined experience in manufacturing, developing and licensing vaccines and protein/antibody therapeutics.

Ology Bio-services is a full-service Contract Development Manufacturing Organization specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in our state of the art Advanced Development and Manufacturing ADM) facility in Florida. Ology Bio has 20 years of experience developing and manufacturing drugs and biologics for the US Government, and over $500M in government contracts awarded over that time.

The company expanded to Commercial Manufacturing upon the move into the new facility in early 2017. Our infrastructure provides unique services to our clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3).We offer outstanding career growth opportunities, excellent fringe benefits, and competitive pay.

We are an Equal opportunity Employer
AA/EEO Minor
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