Expert Microbiologist in Quality Control

3 days ago

Rockville, Maryland, United States Alphanumeric Systems Full time
Job Title: Expert Scientist in Quality Control Microbiology

We are seeking an experienced and skilled Expert Scientist in Quality Control Microbiology to join our team at Alphanumeric Systems. As a key member of our quality control team, you will be responsible for implementing new and rapid microbiology technologies to ensure data integrity, meet quality standards, and support regulatory submissions and delivery of quality medicines for patients.

Responsibilities:
  • 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 and implementation of compliant, state of art methodology and instrumentation.
  • Provide scientific understanding and analytical support for development of new test method, validation, and specifications.
  • Support for scientific report writing and document revision.
  • Provide analytical troubleshooting support for investigations which require non routine/specialized service.
  • Support microbiology technology validation and implementation for testing pharmaceutical products and manufacturing environment.
  • Provide validation and testing data for these 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.
  • Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.
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.
Preferred Qualifications:
  • An understanding of the theoretical and practical aspects of Pharmaceutical Microbiology (knowledge of rapid/alternative methodologies an advantage).
  • Demonstrated hands-on and/or practical experience in endotoxin detection methods of pharmaceutical products and/or water.
  • Capacity to think innovatively and flexibly for new microbiology methodology implementation, comfortable with complexity.
  • Experience in microbiology method and equipment development and/or validation.
  • Knowledge of biological and pharmaceutical product manufacturing and microbial control.
  • Experience with FDA regulations.

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