QC Microbiologist

QC Microbiologist - Rockville, MD - Contract

Proclinical is seeking a dedicated and innovative QC Microbiologist with a focus on endotoxin detection methods. This is a contract position located in Rockville, MD.

Primary Responsibilities:

This role offers the unique opportunity to implement cutting-edge technology into biological and pharmaceutical products and processes.

Skills & Requirements:

• BSc in Biological Sciences or related area; Microbiology, Biochemistry or a related subject.
• Experience 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 skills in English.
• Self-motivation.
• Understanding of the theoretical and practical aspects of Pharmaceutical Microbiology.
• Experience in endotoxin detection methods of pharmaceutical products and/or water.
• Capacity to think innovatively and flexibly for new microbiology methodology implementation.
• Experience in microbiology method and equipment development and/or validation.
• Knowledge of biological and pharmaceutical product manufacturing and microbial control.
• Experience with FDA regulations.

The QC Microbiologist will:

• Drive the implementation of new and rapid microbiology technologies that ensure data integrity, meet our 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 service.
• Support microbiology technology validation and implementation for testing pharmaceutical products and manufacturing environment.
• 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.
• Adhere to GMP standards as appropriate.
• Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC