Expert Scientist in Quality Control Microbiology

3 weeks ago


Rockville, Maryland, United States Alphanumeric Systems Full time

We are seeking a highly skilled Expert Scientist in Quality Control Microbiology to join our team at Alphanumeric Systems. This is an exciting opportunity to work with our client of 20 years, committed to improving lives through medical and pharmaceutical advancements.

The ideal candidate will have experience or specialty in endotoxin detection methods and a strong understanding of method development, method validation/qualification, and GMP laboratory operations.

Responsibilities:

  • Drive the implementation of new and rapid microbiology technologies to ensure data integrity, meet quality standards, and support regulatory submissions.
  • Design and execute method development and GMP validation for recombinant factor C endotoxin testing.
  • Contribute to method development and method qualification.
  • Perform laboratory operations to support the implementation of compliant, state-of-the-art methodology and instrumentation.
  • Provide scientific understanding and analytical support for the development of new test methods, validation, and specifications.
  • Support scientific report writing and document revision.
  • Provide analytical troubleshooting support for investigations requiring non-routine/specialized services.
  • Support microbiology technology validation and implementation for testing pharmaceutical products and manufacturing environments.
  • Provide validation and testing data for new methods and technologies for internal advocacy and external regulatory submission.
  • Facilitate method transfer, validation, and implementation of new microbiology technologies at secondary commercial sites.
  • Work to GMP standards as appropriate.

Requirements:

  • BSc in Biological Sciences or related area; Microbiology, Biochemistry, or a related subject.
  • 3 years or more experience in working in research and/or analytical development and/or quality control functions.
  • Demonstrated experience and good working knowledge of method development, method validation/qualification.
  • Experience with GMP laboratory operations.
  • Strong team working skills, able to perform collaborative work across interdisciplinary groups.
  • Strong desire to learn/scientific curiosity, with cross-functional learning agility.
  • Good organizational skills, ability to multitask and adapt to fast-changing priorities and deadlines.
  • Excellent verbal and written communication (English).
  • Self-motivation.

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