Position Summary
The Project Microbiologist duties and functions include technical and management abilities to perform duties as experts in all aspects of microbiology.
Essential Responsibilities
- Perform routine testing on samples in a timely manner with no supervision; record results, track and meet assigned testing deadlines
- Perform maintenance, calibration and troubleshooting of assigned equipment and systems in order to meet testing deadlines; ensure all equipment and systems are operating within established calibration guidelines; notify manager promptly of calibration failures and repair needs
- Manage isolation and maintenance of cultures of bacteria or other microorganisms in prescribed or developed media, controlling moisture, aeration, temperature, and nutrition
- Examine characteristics to identify and classify microorganisms
- Maintain expertise for a variety of specialized microbiology laboratory equipment
- Direct optimization procedures for microbial growth, stabilization and product formulations
- Implement strict documentation standards for all work performed in the laboratory
- Plan and organize the laboratory’s day to day operations, including roles and responsibilities of micro staff
- Communicate technical and scientific information effectively to staff, management, and customers
- Enforce, train, supervise safe training and protocols for micro staff
- Maintain the highest standards for technical excellence and ethical behavior in all aspects of work and personnel interaction
- Prepare technical reports and recommendations based upon research outcomes
- Comply with Company policies, cGMPs, ISO 17025, and all applicable SOPs
- Assist with laboratory compliance audits and laboratory safety audits
- Support validation activities
- Accurately identify, monitor, and repot microbiological trends
- Provide technical review of adverse trends, action limit reports, and discrepancies
- Generate specifications for relevant inventory
- Order and maintain inventory
- Attend tradeshows and provide sales training
- Performs all other duties as Microbiologist II
- Write, revise and review SOPs in a timely manner, as required
- Assist with special projects, as assigned
- Performs all other duties, as required
Qualifications
- Bachelor’s degree in Microbiology or related science field, including at least 12 semester hours of hands on laboratory courses in microbiology and/or chemistry. Master’s degree preferred
- Five years of pharmaceutical/biochemical QC laboratory experience in a microbiology setting
- Ability to understand and comply with Company policies and SOPs, including safety rules and regulations
- Demonstrated experience in a microbiology laboratory (Q.C., pharmaceutical, biotech or clinical lab experience preferred), where one or more of the following functions was successfully performed: sterility testing, endotoxin testing, antibiotic assays, environmental monitoring, microbial identification and/or microbial limit testing (MLT)
- Excellent analytical, decision making and interpersonal skills
- Excellent verbal and written communication skills
- Working knowledge and understanding of microbiology principles and methods and the ability to communicate this information to others
- Ability to solve routine and non-routine laboratory issues
- Physical dexterity to accurately and precisely perform testing
- Intermediate level computer skills in Microsoft Office, Word, Excel, PowerPoint, Outlook and the Internet
Certifications:
Certified pharmacy technician, a plus
