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Job Title: Analytical Chemist
Category:  Professional & Business Operations

  • Analytical chemist with experience in generic product method development and validation. 

  • Hands-on experience in common analytical tools such as HPLC, GC, dissolution testing etc.

  • Ability to work in a team with excellent spoken and written communication skills.


  • Chemist with background in organic, analytical or physical chemistry, who has worked in analytical method development of drug products for ANDA or 505 b(2) filings.

  • This person should be well versed in common pharmaceutical analytical tools and have previous experience in validating methods as per ICH guidelines.

  • In addition, they should be able to troubleshoot methods and work with formulation scientists in developing discriminating dissolution methods, identifying unknown impurities and transferring methods to the quality control (QC) laboratory.

  • Suggest improvements and efficiencies in the department. Assist in revising and maintaining SOPs, operating procedures and other documents. Suggest new equipment and or training for personnel.

    • 60%      Daily Review, plan, design and execute experiments for analytical development & validations

    • 20%     Analyze data and summarize in form of reports

    • 10%     Review literature, reports, protocols and approve them

    • 5%        Discuss, prioritize and plan work with external functions such as PD and QC

    • 5%       Provide feedback to senior management on project progress

  • MS or PhD in Analytical Chemistry or related field

  • Analytical method development & validations with 3 - 6 years of experience in the generic drug industry.

  • Experience in working with DEA controlled drug substances and relevant regulations.

Location  Dayton , NJ
Minimum Experience (yrs):  3+
Required Education:  Not Specified

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