28 days old

Senior Scientist of Analytical Research & Development - Direct Hire

Kelly Services
Durham, NC 27722
Kelly Scientific is currently seeking a **Senior Scientist of Analytical Research & Development for** a **DIRECT HIRE** opportunity in **Durham, NC.**

+ Capable of troubleshooting and validating test methods for complex formulations, especially inhalation products.

+ Capable of developing methods with some support and guidance.

+ Strong GC method development skills are required.

+ Analytical experience with small molecule based formulations is preferred.

+ Experience with common analytical instruments and familiarity with Metered Dosage Inhaler (MDI) testing is preferred.

**Key Responsibilities:**

+ Will support formulation development work by developing (with some guidance and support) and validating suitable analytical test methods, with a focus on GC methods.

+ Will perform hands-on lab work and may coordinate work with junior level analytical staff. Need to provide routine characterization of the R&D formulations and should provide analytical support for studies necessary for chemistry and manufacturing controls. In addition, should be capable of troubleshooting methods and work with formulation scientists in developing assay methods (active and critical excipients), fast LC methods for DDU and APSD analytical finish, and transferring methods to the quality control (QC) laboratory.

+ Must be able to draft test methods, method validation protocols and reports as per FDA and ICH guidelines and should follow cGMP. Ability to guide junior level analytical scientists and chemists is preferred and should work closely with formulation scientists. Good oral and written communication skill and working in a team environment


Troubleshoot equipment problem and work with instrument manufacturer to resolve issues. Coordinate equipment qualification and calibration. Organize and maintain laboratory for efficient operation.


+ BS in Chemistry or related with 7+ years of experience (pharmaceuticals or related) or MS with 5+ years or Phd. with 2+ years of experience (pharmaceuticals or related

+ Experience in test method validation

+ Experience with HPLC and GC, including strong GC MD skills

+ Must be able to perform laboratories duties that require standing for up to 90% of the work day, lifting containers containing up to 4+L of liquids and fine motor skills for conducting laboratory experiments (including weighing and pipetting).


+ Experience with test method development

+ Experience with MDI product testing

+ Experience developing generic products, including inhalation products

+ Familiarity with cGMP regulations, FDA guidance documents and QbD

+ Able to wear a respirator.

Apply Today for Immediate Consideration!

**Why Kelly** **** **?**

Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2020-05-04 Expires: 2020-06-13

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Senior Scientist of Analytical Research & Development - Direct Hire

Kelly Services
Durham, NC 27722

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