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Analytical Scientist CMC

  • Cambridge, MA
  • March 12, 2020
Company
Our client is seeking a Scientist to join the CMC Analytics group, which performs/manages analytical development activities to support our products, intermediates, and starting materials.
Responsibilities
  • Independently develop new analytical methods and optimize existing analytical methods to meet our drug development needs.
  • Manage external resources to perform method development, testing, and validation activities 
  • Review analytical protocol/report/result generated by internal/external personnel 
  • Follow established procedures to test quality attributes using various techniques, including but not limited to pH, osmometry, viscosity, UV, IR, IC, LC-MS. 
  • Participate in lab maintenance and coordination of instrumentation repairs/maintenance. 
  • Analyze, interpret, and present experimental data in multidisciplinary team meetings. 
  • Coordinate with process development, engineering, and biology team members to manage analytical workflow and ensure timely delivery of results. 
  • Maintain detailed records in electronic laboratory notebook following quality guidelines.
  • Assist to manage technical transfers to CMOs 
Requirements
  • BS/MS/PhD in chemistry or biology with an analytical concentration 
  • Minimum of 5 years of industry experience in pharmaceutical/biotechnology 
  • Extensive development and troubleshooting experience on chromatography & mass spectrometry 
  • Extensive experience working in a GLP/GMP environment 
  • Experienced with method qualification/transfer/validation following guidelines 
  • Experienced with drafting protocol/report and reviewing others 
  • Hands-on experience on light scattering and/or microscope techniques is preferred 
  • Working knowledge of biopolymers and/or medical devices is desired 
  • Able to take detailed notes and observations about experimental design, process, results, and analyses and to record those experimental results in both ELN and presentation format 
  • Able to mentor junior team members 
  • Able to set priorities and multi-task activities to effectively manage workflows and deliverables 
  • Great team player 
  • Good written and oral communication skills 
  • Must have the authorization to work in the United States

Experience

5 to 10 (Yrs)

Required Skill Set

Chromatography Mass Spectrometry GLP GMP Medical Devices ELN CMOS UV IR IC Analytical Methods Light Scattering Microscope Techniques Biopolymers Analytical Workflow Instrumentation Repairs/maintenance PH Osmometry Viscosity LC-MS Analytical Protocol Test Quality Attributes

Salary

$ DOE per Year

Job Type

Full Time

Telecommute

No

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