Job Description
Work Schedule Standard (Mon-Fri)
Environmental Conditions Office
Job Description Overview Seeking a highly skilled scientist with experience in pharmaceutical microbiology testing and the ability to apply that knowledge to the introduction of innovative solutions in this area. This is an exciting and unique role where the applicant will have the opportunity to implement novel microbiology methods into biological and pharmaceutical products. The successful applicant will focus on the development and validation of transformational microbiology methodologies, driving execution of proof of concept studies, validation and implementation into biological and pharmaceutical products and processes.
Key responsibilities - Support rapid microbiology technology development and implementation for testing pharmaceutical products and manufacturing environment.
- Seek rapid/alternative microbiological technologies for microbiological tests (such automated colony counters, rapid bioburden, sterility, mycoplasma and adventitious viral agent assays).
- Review the technologies and advise on their feasibility.
- Design and execute proof of concept studies for new rapid microbiology technologies.
- Design and execute method development and GMP validation for these new methods.
- Provide validation and testing data for the new method for internal advocacy and external regulatory submission.
- Maintain training records and familiarity with current SOPs and controlled documents
- 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.
Qualifications: - BSc in Microbiology, Biochemistry or a related subject.
- 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 microbiological analysis of pharmaceutical products, including sterility, bioburden, microbial limits and bacterial endotoxins testing, and environmental monitoring.
- Able to provide original thinking for microbiology method development, with particular focus on new and rapid microbiology testing.
- Experience with GMP laboratory operations and FDA regulations
- Strong team working skills, able to effectively work across interdisciplinary groups
- Capacity to think innovatively and flexibly, comfortable with complexity.
- Strong desire to learn/scientific curiosity, with cross functional learning agility
- Good organizational skills and ability to multi task
- Excellent verbal and written communication
Preferred Qualifications - Experience in microbiology testing method development/validation of pharmaceutical products.
- Knowledge of new and rapid microbiology methods
- Experience with molecular techniques such as qPCR and NexGen sequencing.
- Ability and interest to apply skills to evaluate and develop new and modern microbiology testing technologies,
•Knowledge of biological and pharmaceutical product manufacturing and microbial control. - Experience with FDA regulations.
Thermo Fisher Scientific
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