Associate Scientist, Pharmaceutical Analysis-Microbiology

at  Frontage Laboratories

POSITION SUMMARY:

Performs routine and non-routine microbiology sample analysis (specifically, MLT/Bioburden, Endotoxin, Environmental Monitoring, Sterility, and AET) and a variety of tasks to support product development, ensuring agreed timelines.

REQUIREMENTS:

• B.S. in Biology or related discipline with 1-3 years relevant experience in pharmaceutical or related industry (CRO experience is a plus)
• Experience in pharmaceutical product and facility testing (MLT/Bioburden, Sterility, Endotoxin, Environmental Monitoring, AET)
• Experience working in a BSL2 laboratory is a plus
• Capable of setting priorities based in a fast-paced, changing environment
• Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams.
  Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability

• Performs method development and validation under supervision
• Prepares study protocols, reports, investigation reports, and generates cGMP documents as needed
• Performs quality checks of data, laboratory notebooks, and other scientific documentation as required
• Maintains qualification and compliance of instruments, and conducts technical and equipment troubleshooting as needed
• Reports and resolves any unexpected issues under supervision
• Complies with all relevant cGMP regulatory requirements while carrying out assigned studies
• Collaborates with team members (Analytical Scientists, Quality Assurance, Material Coordinators, and Manufacturing Technicians) to meet timelines for drug product delivery
• Identifies opportunities for improvement in quality of services, and works with the team to implement