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Sr. Manager, R&D (Science & Biotech)
Durham, NC 27709
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Feb 07, 2019
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Job Description

Will support formulation development work by developing, troubleshooting, and validating suitable analytical (LC, GC) test methods quickly and efficiently. Examples include assay and related subs methods for actives, fast LC methods for DDU and APSD, and GC and LC methods for excipients. Will perform hands-on lab work as well as direct, develop and train analytical scientists. Will provide routine characterization of R&D formulations and analytical support for studies necessary for chemistry, manufacturing and controls (CMC). In addition, will transfer methods to the quality control (QC) laboratory. Troubleshoot equipment problems and work with instrument manufacturer and third party service providers to resolve issues. Coordinate equipment qualification and calibration. During product transfer, work closely with QC for method transfers, ensuring smooth transfers. During pre-approval inspection audits, provide required scientific help justifying test methods, as required.

QUALIFICATIONS

Expert in developing, troubleshooting and validating chromatography test methods for complex formulations for metered dose inhaler (MDI) products. Analytical experience with small molecule based formulations is required. Experience with common analytical instruments (e.g. LC, GC) and familiarity with MDI analytical and performance testing is preferred. Must be able to write SOPs, test methods, method validation protocols, and reports as per FDA and ICH guidelines and follow cGMP. Strong leadership skills are required for direct supervision of analytical scientists and chemists, including providing career development. Will work closely with formulation scientists. Exceptional oral and written communication skills and working in a team environment. BS with 15+ years of experience (pharmaceuticals or related) or MS or PhD in Analytical Chemistry with 10+ years of experience (pharmaceuticals or related). Expert in test method development, troubleshooting, and validation. Experience with HPLC, GC, and other relevant analytical instrumentation. Strong technical writing skills.