Responsible for developing new procedures, executing microbiological method validations, conducting investigations, finding root causes, writing technical reports, assisting on environmental monitoring (EM), and performing microbiological tests of components, raw materials, in-process, stability and finished product samples.
- Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules.
- Team player with well-developed interpersonal, organizational, and communication skills.
- Maintains proper social etiquette and self-control when dealing with stressful situations.
- Three or more years of hands-on experience developing and validating microbiological methods per USP and EP to include MET/TSM, Bile Tolerant Gram-Negative Bacteria, BCC, Antimicrobial Effectiveness Tests and Particulate Matter Analysis via
Responsibilities and Essential Skills:
- Review and approve laboratory data.
- Develop microbiological methods.
- Write protocols and execute microbiological method validations.
- Conduct investigations, determine root cause and applicable CAPAs.
- Lead microbiological related projects to implement new methodologies.
- Participate in the validation of plant systems and manufacturing processes.
- Participate on drug product development teams.
- Train personnel in microbiological methods.
- Demonstrated knowledge of pharmaceutical microbiology techniques.
- Perform trend analysis of EM results.
- Working knowledge of current Good Manufacturing Practices (cGMPs)
- Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports.
- Perform routine and batch EM.
- Perform incoming raw material and component testing, in-process analyses, finished product release testing and stability testing.
- Maintain the laboratory in accordance with SOPs.
- Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventive maintenance and troubleshooting.
- Other duties as assigned.
- Bachelors degree in Microbiology, Biology or related field with at five years of relevant experience in an FDA regulated cGMP environment
- Masters degree with at least three years of relevant experience; or Ph.D.
Job Type: Full-time
- hands-on experience developing and validating microbiologica: 3 years (Preferred)
- pharmaceutical microbiology: 3 years (Preferred)