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Analytical Scientist

Location

Durham, NC, USA

Department

Analytical Support

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

As an Analytical Scientist, you will develop and validate analytical methods for testing of drug substances and drug products.

Responsibilities

  • You will operate HPLC, Dissolution, GC, KF, and other laboratory equipment.
  • Additionally, you will write standard operating procedures (SOPs), method validation protocols, method validation reports and specifications.
  • As an Analytical Scientist, you will supply weekly updates on long-term projects.
  • With guidance, you will prepare well written and organized development reports to convey the quality of the methods to clients.
  • Assist in writing new SOPs, implementing efficient and effective workflows, and onboarding new methods and instruments in a growing group in a fast-paced work environment.
  • May spend 60-80% of time in the lab and 40-20% writing methods, reports, protocols, and SOPs
  • Work effectively in a team environment to grow capabilities and add value to the customer
  • Draft and release certificates of analyses, reports, protocols, and methods per cGMP and ICH practices
  • May interact with clients to report on method development activities/results

Qualifications

  • Excellent academic and professional record with demonstrated laboratory skills and the ability to work in an interdisciplinary team environment.
  • 3 – 5+ years’ experience in chromatography and wet analytical chemistry is required.
  • Strong analytical chemistry skills, including HPLC, Dissolution, GC, and wet chemical methods.
  • Strong technical writing skills in protocols and reports
  • Experience operating HPLC, and GC equipment and executing method validations and transfers.
  • Experience in a cGMP environment is required.
  • Knowledge of USP, EP, FDA and ICH requirements as they apply to production of drug substances and drug products is preferred.