Required - Scientist, I/II, Analytica...
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Required – Scientist, I/II, Analytical Development!
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The individual in this role will conduct quality scientific analytical experimentation to support development of robust formulations. He/she will develop and validate analytical methods with minimal guidance.  Knowledge of standard analytical chemistry techniques common to small molecule pharmaceutical development, particularly HPLC analysis, is required.  The successful candidate will work effectively independently, but also be capable and willing to oversee the work of more junior staff on an as needed basis.  Knowledge of cGMP and other relevant regulations is required.

  • With minimal guidance, executes the development, validation and transfer of analytical methods and the testing of drug products, including but not limited to dissolution, assay, and impurities.
  • Supports continuous improvement efforts in lab procedures, develops best practices and obtains appropriate training, and ensures compliance to Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs).
  • With minimal guidance, performs quality scientific experimentation to develop robust analytical methods. Implements Quality by Design (QbD) / Design of Experiment (DOE) concepts in methods development where appropriate. Makes sound scientific conclusions and decisions.
  • Documents analytical testing using good documentation practices.
  • Drafts analytical methods, protocols, and reports with minimal guidance, executes laboratory investigations and study protocols.
  • Troubleshooting and resolve problems related to analytical methods and laboratory instrumentation.
  • Collaborates with multidisciplinary teams, including product development, quality, and regulatory.
  • Help train junior personnel in laboratory job functions.
  • Prepares analytical data for regulatory submissions.
  • Supports investigations for deviations and ensures proper corrective actions are taken.
  • 5-8 years of relevant experience with a Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, or equivalent
  • 1-4 years of relevant experience with a Master’s Degree or PhD in Chemistry, Biochemistry, Pharmacy, or equivalent
  • Must have basic knowledge and training in using a variety of laboratory instruments and techniques in the pharmaceutical industry, i.e. HPLC, wet chemistry, etc.
  • Must have experience in an R&D or quality control work environment, demonstrating flexibility and adaptability to changing business needs such as changing project priorities, work assignments, etc.
  • Previous experience with dissolution is preferred. Experience with modified-release drug products is also a plus.
  • Strong written and verbal communication skills required.

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