Pace Analytical

Chemist - Method Development

US-MN-Maplewood
ID
2018-2036
# of Openings
2
Category
Science

Overview

The successful candidate will independently perform analytical testing, method development and method validation to support the clinical trial process of a drug delivery device. Analytical lab experience working with HPLC and/or UPLC is critical.

Responsibilities

  • Independently develop, optimize, tweak and validate analytical methods using the HPLC, UPLC and/or LC-MS
  • Complete associated technical documentation – protocols, development and validation reports, specifications, etc.
  • Carry out complex experiments involving a variety of lab skills to achieve project goals
  • Conduct stability testing using in-process or developed methods
  • Comply with FDA guidelines and SOPs in a cGMP environment
  • Performs dissolutions, extractions and other preparatory techniques on samples
  • Gathers and records data according to SOP and protocol guidelines, and performs technical evaluation of data to analyze, interpret and report on results
  • Communicates with staff and clients as needed throughout the analytical process to ensure compliance with protocols and SOPs
  • Maintains and troubleshoots analytical equipment as required

Qualifications

  • Bachelor's degree in chemistry or a related scientific field
  • Experience independently developing and validating methods for the HPLC, UPLC and/or LC-MS
  • Working knowledge of GMP and applicable ISO standards is preferred
  • Ability to independently troubleshoot instrumentation
  • Ability to work in a fast-paced environment
  • Ability to meet deadlines and multitask
  • Flexibility with changing priorities
  • Excellent computer skills
  • Experience with Empower 3 software a plus
  • Experience with ELN software a plus

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