Scientist III

• Pay: $60-70/hr.
• 6-month assignment with possibility for extension or conversion based on performance and budget.

Responsibilities: 

• Perform routine and non-routine bioassay testing for raw materials, in-process samples, stability samples, and finished products.
• Operate and maintain Hamilton Microlab star automated liquid handling systems for bioassay preparation and sample processing.
• Familiar with BioStat, PLA, SoftMAx Pro etc statistical software for Hamilton bioassay testing.
• Conduct qualification activities for laboratory instrumentation including but not limited to Hamilton, Rheometers, FT-IR, CCIT, UV Spectrophotometer etc.
• Prepare technical reports, SOPs, protocols for qualification of instruments and investigation documentation in compliance with cGMP, FDA, and ICH guidelines.
• Support method qualification, validation, and transfer activities.
• Perform instrument calibration, troubleshooting, maintenance, and documentation.
• Work effectively with others to achieve shared goals and perform weekly trending meetings for qualification/upgradation activities.
• Interact with external vendors on technical matters requiring coordination for qualification activities.
• Work independently with minimal supervision and direction in compliance with cGMPs.
• Practice safe work habits and adhere to ThermoFisher's safety procedures and guidelines.

Qualifications:

• Bachelor's Degree in Life Sciences discipline and 6-8 years’ experience in cGMP lab environment, or a
• Master's Degree in Life Sciences discipline and 5 years’ experience in cGMP lab environment 
• Proficient in Outlook and Microsoft Word and Excel and lab-based data management systems (required)
• Scientific technical writing ability (required)
• BioAssay (Hamilton Microlab Star) with BioStat, PLA or SoftMax Pro software (preferred)
• Rheometers, FT-IR, UV Vis Spectroscopy and CCIT (preferred)
• Experience with instrument and software Qualification (preferred)
• Knowledge of lab-based data management systems (preferred)
• Familiarity with FDA and USP global compendia requirements (preferred)