Principal Scientist-Quality Control, Instrumentation

JOB DESCRIPTION

• Monitor and coordinate instrument installation and maintenance.
• Operate basic, moderately complex, and complex cGMP Quality Control equipment.
• Manage all aspects of laboratory equipment lifecycle.
• Manage all aspects of equipment vendor management.
• Prioritize and schedule activities to meet deadlines.
• Interact as an SME for internal and external entities.
• Lead training of specific analytical instruments and processes.
• Perform self-review of analytical data for accuracy and consistency with SOP.
• Perform general lab housekeeping in adherence to 5S standards.
• Complete routine and preventive maintenance on basic, moderately complex, and complex equipment.
• Participate in team meetings and/or training sessions.
• Write technical documents.
• Maintain and troubleshoot Quality Control equipment.
• Perform the foregoing using
  • Lean Six Sigma
  • Clean room procedure, aseptic technique, and general lab equipment experience
  • cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP)
  • following standard operating procedures (SOP)
• Use the following laboratory equipment:
  • Agilent, Waters, and Thermo HPLC/UHPLCs (with VWD, MWD, DAD, CAD, ELSD)
  • LC/MS
  • GC
  • Sciex PA800 Plus (including LIF detector)
  • Protein Simple iCE3 and Maurice
  • Biotech and Molecular Devices Plate Washers and Plate Readers
  • Applied BioSystems 3500xL
  • Applied BioSystems 7500 Fast
  • Controlled Temperature Units (multiple vendors)
  • pH Meters (multiple vendors)
  • Balances (multiple vendors)
  • Pipettes (multiple types and multiple vendors)

EDUCATION AND EXPERIENCE REQUIREMENT

Requires a Bachelor’s degree in Pharmaceutical Sciences or Related Field and 8 years of experience in job offered or 8 years of experience in the Related Occupation

RELATED OCCUPATION

Chemist or any other job title performing all listed job duties.

JOB TIME

Full Time