Pace Analytical

Chemist - Method Development

Job Locations US-MN-Maple Grove
ID
2018-2096
# of Openings
1
Category
Science

Overview

The successful candidate will independently perform analytical testing, method development and method validation.

Responsibilities

  • Independently develop, optimize, and validate analytical methods using the HPLC and GC
  • Complete associated technical documentation – protocols, development and validation reports, specifications, etc.
  • Carry out complex experiments involving a variety of lab skills
  • Conduct stability testing using in-process or developed methods
  • Comply with FDA and ICH guidelines and SOPs in a cGMP environment
  • Perform dissolutions, cleaning validations, assay, cleaning/blend uniformity, and other techniques
  • Gather and records data according to SOP and protocol guidelines, and perform technical evaluation of data to analyze, interpret and report on results
  • Assist with establishing specifications for APIs, excipients and drug products. Develop justification of these specifications to be included in regulatory submissions

  • Critically review and evaluates stability data. Establishe trends between multiple studies. Recommend and assist with establishing shelf life of new drug products

  • Coordinate the gathering of necessary documents and assists with writing portions of the CMC submission document

  • Lead projects/studies, and ensure they are completed according to established timelines

Qualifications

  • One of the following:
    • BA/BS in Chemistry or a related scientific field (at least 12 credits of college chemistry) AND five years analytical experience, preferably in the pharmaceutical industry
    • MS degree with 3 years of experience in analytical method development in a drug product pharmaceutical industry
  • Advanced knowledge of HPLC, GC, dissolution, FDA, and ICH guidelines
  • Experience with method development and method validation in a cGMP lab environment, PC's, cGMP's, and USP testing.
  • Proven problem solving, communication, and technical skills

  • Ability to meet deadlines and multitask
  • Excellent computer skills

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