Microbiologist I

Medvacon Life Sciences • East Windsor, NJ

2d

About The Position

POSITION OVERVIEW: The Microbiologist I performs essential microbiological testing to ensure the safety and quality of pharmaceutical products while maintaining strict compliance with current Good Manufacturing Practices (cGMP). This role supports test method development, executes sterility, bioburden, and endotoxin testing, and plays a key role in cleanroom and environmental monitoring. By upholding the highest standards of accuracy and collaboration, the Microbiologist I helps advance our mission to expand access to affordable, innovative medications that improve lives. ESSENTIAL JOB FUNCTIONS: Supports microbiological sampling and testing of raw materials, finished products, and environmental monitoring samples using methods such as bioburden, sterility, endotoxin, and total organic carbon, while adhering to International Organization for Standardization cleanroom protocols involving gowning and routine sample handling. Assists with microbial identification, growth promotion, and antimicrobial effectiveness testing, and supports laboratory investigations through root cause analysis of Out of Specification results and implementation of corrective actions. Documents procedures, results, and observations accurately in compliance with laboratory protocols, safety guidelines, and regulatory standards, including cGMP, while also performing data trending and general laboratory equipment maintenance. Collaborates with cross-functional teams, communicates findings clearly, and contributes to research discussions, project meetings, and the development and validation of microbiological test methods. Follows United States Pharmacopeia (USP) regulations, maintaining personal hygiene, garbing, and Personal Protective Equipment standards in sterile and nonsterile, hazardous and nonhazardous labs.

Requirements

• Minimum of 1 year of laboratory experience required; pharmaceutical or compounding experience preferred.
• Bachelor's degree in microbiology, biology, biochemistry, or related scientific field required.
• Strong analytical and problem-solving skills with the ability to work collaboratively, adapt to evolving priorities, and communicate technical findings effectively.
• Proficiency in microbiological testing techniques, method development, and validation, including bacterial endotoxin testing, sterility, microbial limit testing, and familiarity with compendial testing and regulatory standards such as USP, Food and Drug Administration, and cGMP.

Responsibilities

• Supports microbiological sampling and testing of raw materials, finished products, and environmental monitoring samples using methods such as bioburden, sterility, endotoxin, and total organic carbon, while adhering to International Organization for Standardization cleanroom protocols involving gowning and routine sample handling.
• Assists with microbial identification, growth promotion, and antimicrobial effectiveness testing, and supports laboratory investigations through root cause analysis of Out of Specification results and implementation of corrective actions.
• Documents procedures, results, and observations accurately in compliance with laboratory protocols, safety guidelines, and regulatory standards, including cGMP, while also performing data trending and general laboratory equipment maintenance.
• Collaborates with cross-functional teams, communicates findings clearly, and contributes to research discussions, project meetings, and the development and validation of microbiological test methods.
• Follows United States Pharmacopeia (USP) regulations, maintaining personal hygiene, garbing, and Personal Protective Equipment standards in sterile and nonsterile, hazardous and nonhazardous labs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1-10 employees