Scientist II, Microbiologist

About the role

The Microbiology Analyst II is responsible for the complete testing and results documentation for Environmental Monitoring, Purified Water, Raw Materials, In-Process, Finished Product, Calibrations, Stability, AD, and Technical Service samples or projects within the QC Microbiology Laboratory, in a manner consistent with established standards.

Responsibilities

• Calibrations/Standardizations/Preparatory Set Up (up to 10%)
  • Perform calibrations of instruments such as balances, pH meters, and Water Activity Meter as required by Patheon/Thermo Fisher Work Instructions.
  • Perform Growth Promotion and Suitability Testing including associated reports.
  • Prepare media, collect purified water for testing, and use the Autoclave for waste disposal.
  • Generate quarterly Environmental and Purified Water Reports.
• Testing/Documentation (up to 80%)
  • Independently perform core techniques or methods as assigned for testing on raw materials, in-process, release, stability, environmental, or technical service samples or projects.
  • Demonstrate proficiency in Microbiological Testing and understanding.
  • Ensure that the calibration of critical laboratory equipment is current before use.
• Housekeeping (up to 5%)
  • Clean (5S) and organize all laboratory areas including benches, sinks, drawers, cabinets, solvent cabinets, refrigerators, freezers, and storage areas.
  • Clean Biological Safety Cabinets (BSC).
  • Maintain laboratory instruments by disposing of wastes, cleaning them, and replacing consumable parts as required.
  • Dispose of solvent, acids, and other wastes according to Patheon/Thermo Fisher procedures and local regulations; clean Biohazard Containers.
• Training and Development (up to 5%)
  • Participate in ongoing training for the development of skills and responsibility with an emphasis on technology.
  • Assist in the training of other analysts in areas of expertise.
  • Actively participate on various laboratory projects or teams and propose solutions to problems encountered by such teams.

Requirements

• Bachelor’s degree in Chemistry, Microbiology, Biology, Biochemistry, or a related field with a minimum of 2 years of related experience in an analytical laboratory setting, preferably in a Quality Control Laboratory in a GMP facility.
• OR a Master’s degree with a minimum of 1 year of related experience.

Qualifications

• Ability to operate laboratory equipment such as microscopes, autoclaves, incubators, water baths, and analytical balances.
• Manual dexterity to use pipets, volumetric flasks, general glassware, laboratory instruments, and fragile accessories.
• Proficiency using a PC and Microsoft Word and Excel.
• Strong mathematical skills.
• High level of commitment to delivering timelines and milestones to achieve business objectives.
• Ability to apply GMP regulations and international guidelines to all aspects of the position.
• Excellent communication and listening skills.
• Knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.
• Must comply with PSG Controlled Substance Policy and meet applicable DEA security clearance requirements if requested.

Benefits

• Medical, Dental, & Vision benefits effective Day 1
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement