Senior Microbiologist

We are seeking a highly skilled Senior Microbiologist to join our team at Alphanumeric Systems in Rockville, MD. The ideal candidate will have experience in quality control microbiology and a strong background in endotoxin detection methods.

The successful candidate will be responsible for implementing new and rapid microbiology technologies to ensure data integrity, meet quality standards, and support regulatory submissions. This is an exciting opportunity to work with novel technology and contribute to the development 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 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 that require 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.
• Follow safe laboratory practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.

Minimum Qualifications:

• 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.