Research Associate II, Product Development

Durham, NC


Duration: 7-36 months


Rate: Negotiable


Salary: NA, $1.00


Responsibilities

• Excellent employment opportunity for a Research Associate II, Product Development in the Durham, NC area.
• Support metered dose inhaler (MDI) product development from product definition stages to product approval and launch by conducting development and analytical experiments.
• 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.
• 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.
• May include performing 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.

• University degree, preferably in the field of Chemistry, Pharmaceutics, Biology or Engineering. Some chemistry laboratory course work required.
• B.S. with 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.
• Competency with Microsoft Office (Excel, Word, PowerPoint, and Outlook) preferred.
• Must be able to effectively communicate verbally and through technical writing (documentation of laboratory experiments).
• Must be willing to shave facial hair for respirator use as part of Laboratory responsibilities as needed.