Project Microbiologist

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