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location: Collegeville, Pennsylvania
job type: Contract
salary: $54.46 - 64.08 per hour
work hours: 9 to 5
- 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, including sterility, bioburden, microbial limits and bacterial endotoxins testing, and environmental monitoring.
- 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
skills: Microbiology, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.