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Analytical Chemist II

Department: Analytical Services
Location: West Columbia, SC

ANALYTICAL CHEMIST II

Position Summary:

  • Support quality control testing and research and development activities as needed.
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent.
  • Relies on experience and judgment to plan and accomplish goals.
  • Perform a variety of tasks and works under general supervision.

Primary Accountabilities:

NOTE: The Primary Accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager.

  • Conduct routine laboratory testing for raw materials, in-process materials, finished product and stability samples in accordance with approved analytical methods.
  • To conduct laboratory work using best-practice analytical techniques, and to consistently follow laboratory GDP and cGMP requirements.
  • Perform calibration and routine maintenance of lab equipment as necessary and participate in troubleshooting and minor repair of instrumentation.
  • Execute and report the results of R&D protocols such as methods validations and vendor evaluations to ensure smooth transfer of validated methods from R&D to QC.
  • To verify notebooks, raw data, and COA’s and, on occasion with management authorization, to provide final QC approval for release.
  • To provide training for chemists as needed and directed by management.


 

Knowledge, Skills & Abilities:

  • BS or MS in Chemistry, Biochemistry or a related field required with 2-5 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.
  • Highly skilled in conducting analysis by HPLC, GC, FT-IR, UV/Vis spectroscopy as well as wet chemistry techniques, needing little or no guidance.
  • Must possess excellent analytical skills and problem solving ability, strong attention to detail, sound understanding of cGMP regulations pertaining to laboratory controls and a thorough knowledge of USP and compendia standards.
  • Ability to design, write, review and update standards operating procedures forms and specifications and design new procedures independently, subject to management review.
  • Ability to perform testing and lead root cause analysis for laboratory investigations for OOS and atypical QC test results, subject to management review.
  • Ability to assist R&D in the development and execution of method development and method validation protocol and reports.
  • Ability to effectively communicate with laboratory staff and management as well as other departments and external customers as directed by management.
  • Possess the initiative and follow through to implement, track and achieve on-time completion of projects, as assigned by management.
  • Must strive for continuous improvement in all work activities.
  • The ability to effectively use a multitude of resources and to be accurate and current with data and information.

In order to initiate the application process, please answer the following questions.
Check the box if your answer is yes.

YES 

Do you have the required BS or MS in Chemistry, Biochemistry or a related field required with 2-5 years of pharmaceutical experience preferred? Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.

YES 

Are you highly skilled in conducting analysis by HPLC, GC, FT-IR, UV/Vis spectroscopy as well as wet chemistry techniques, needing little or no guidance?

YES 
Do you possess excellent analytical skills and problem solving ability, strong attention to detail, sound understanding of cGMP regulations pertaining to laboratory controls and a thorough knowledge of USP and compendia standards?YES 
Do you have the ability to design, write, review and update standards operating procedures forms and specifications and design new procedures independently, subject to management review?

Are you able to check "yes" to all the boxes above? 

      

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