Seeking a highly skilled scientist with a demonstrated track record of applying knowledge to the introduction of innovative solutions in the area of Quality Control microbiology testing. This is an exciting and unique role where the applicant will have the opportunity to evaluate novel microbiology methods for testing chemical and biological 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.
• Seek rapid/alternative microbiological technologies for microbiological tests (such automated colony counters and 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.
• Execute method development and GMP validation for the rapid methods.
• Provide validation and testing data for the new method for internal advocacy and external regulatory submission.
• Maintain training records and familiarity with applicable 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.
• BSc in Microbiology 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 - 2-5 years exp.
• Able to provide original thinking for microbiology methodology development, with particular focus on novel on line and off line 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
• Experience with molecular techniques such as qPCR and NexGen sequencing.
• Experience in microbiology method development/validation in pharmaceutical products.
• Knowledge of pharmaceutical environmental and manufacturing microbiology.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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