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Research Associate II, Product Development

Location: Durham, North Carolina, United States
Job # 12222935
Date Posted: 04-24-2019
Research Associate I, Product Development
Durham, North Carolina 27703
$22-$26 per hour DOE
6-month contract

As the Research Associate II, Product Development, you will support metered dose inhaler (MDI) product development from product definition stages to product approval and launch by conducting development and analytical experiments. 

Responsibilities:
  • Conduct laboratory work related to advancing product quality and performance. 
  • Participate in and contribute to the design of well-controlled studies using knowledge of MDI sciences.
  • Trend and analyze data with the use of statistical software, communicate results in technical sub-teams with guidance from senior staff. 
  • Perform data review and transcription verification of technical documents (e.g., reports, regulatory filings). 
  • Perform laboratory work in accordance with relevant protocols and test methods.
  • Perform total can assay using HPLC for analysis, valve force profiling, and simulated use testing with the use of FD-10 for firing down MDIs. 
  • Perform laboratory work in support of product investigations as directed by senior staff. 
  • Familiar with a variety of laboratory techniques and instrumentation including computed tomography, SEM/EDX, and Instron for force profiling. 
  • Review and sign off on colleagues’ notebooks. 
  • Interact with other functional areas (Analytical, NCMF, QA) to get studies conducted and reviewed. 
  • Communicate project status and concerns to team. 
  • Document laboratory work in electronic laboratory notebook following good documentation practices. 
  • Maintain the lab in a cGLP manner and keep up to date with GMP/GSP and safety regulations. 
Qualifications:
  • BS in the field of chemistry, pharmaceutics, biology or engineering. Some chemistry laboratory course work required. 
  • 3-7+ years of pharmaceutical industry experience. 
  • Hands-on laboratory experience with a variety of techniques and equipment is desirable; HPLC/GC experience is preferred. 
  • Familiar with safe laboratory practices. Previous experience working with hazardous materials is preferred. 
  • Proficient in Microsoft Office (Excel, Word, PowerPoint, and Outlook).
  • Must be able to effectively communicate verbally and through technical writing (documentation of laboratory experiments). 
  • If necessary, must be willing to shave facial hair for respirator use as part of lab responsibilities as needed. 
Please submit your resume for consideration!
 
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