Scientist

About the role

A Scientist will support microbiology-related methods such as endotoxin, bioburden, sterility, and other compendial methods associated with microbial control. Hands-on laboratory work includes method troubleshooting and involvement in evaluating new technologies related to rapid microbiology methods, including developing and executing feasibility and/or validation studies. The candidate will work in the laboratory to support these studies, with time spent in the lab varying depending on projects.

This role is part of a team that supports various microbiology methods across different stages of the product life cycle, collaborating with representatives from Process Development, Manufacturing, and Quality. The team supports programs and methods at locations throughout the company.

Responsibilities

• Perform hands-on laboratory work, including method troubleshooting for microbiology-related methods (e.g., endotoxin, bioburden, sterility).
• Evaluate new technologies related to rapid microbiology methods, including developing and executing feasibility and/or validation studies.
• Collaborate with cross-functional teams in Process Development, Manufacturing, and Quality.
• Support microbiology methods at various stages of the product life cycle across company locations.
• Analyze and interrogate complex analytical data sets to drive investigational processes.
• Lead root cause analysis for advanced and complex events.
• Propose and lead new scientific initiatives within the investigational laboratory setting.

Requirements

• Doctorate Degree OR Master’s Degree and 4 years of scientific experience OR Bachelor’s degree and 6 years of scientific experience.
• Experience in pharmaceutical or biotechnology microbiology and manufacturing (preferred).

Qualifications

• Prior experience in Microbiological Quality at the technical level, including sterile filtration validations.
• Advanced understanding and hands-on experience with compendial microbial methods, rapid methods for microbial detection/identification, and advanced technologies for bacterial detection.
• Excellent written and oral communication skills for documenting, presenting, and discussing scientific results in a fast-paced, multidisciplinary environment.
• Advanced ability to critically analyze complex analytical data sets (e.g., complex dilution schemes) to influence investigational processes.
• Expertise in root cause analysis and leading advanced, complex investigations.
• Experience proposing and leading new scientific initiatives.
• Expertise in an investigational laboratory setting within a pharmaceutical or biotechnology company.
• Experience collaborating with scientific and manufacturing disciplines across process development, clinical, and commercial operations.
• Familiarity with cGMP regulations, FDA, and EU regulations and guidelines.

Pay

Target pay range: $29–$39 per hour, depending on experience.