Job Description


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Analytical Scientist

  • Ref: 308226
  • Type: Contract
  • Location: Warren, NJ
  • Industry: Pharmaceuticals
  • Job Level: Experienced Non-Manager
  • Pay: Negotiable

Opportunity Description

The Analytical Scientist will be part of a team of drug development professionals responsible for the continued development and regulatory approval of thin film drug products containing a wide range of therapeutic compounds. 


Company Information


Job Duties

  • Hands-on laboratory analysis of R&D drug substance and drug product samples. 
  • Method development, method transfer and validation of analytical methods developed in-house or from client.
  • Provide analytical support during pre-formulation, formulation development and manufacture of prototype formulations, clinical trial materials and process scale-up.
  • Perform characterization, release and stability testing of raw material and drug product samples for conformance to specifications.
  • Prepare and update/review SOPs for the analytical laboratory.
  • Observe and maintain compliance with applicable DEA and safety regulations, cGLP/GMP guidelines, and Company policies and procedures.
  • Interact in a team atmosphere, providing expertise in general analytical techniques.
  • Troubleshooting and repair of minor problems in analytical instruments.
  • Responsible for laboratory work area housekeeping.
  • Assist with raw data review, analysis, report writing and laboratory investigations (OOT/OOS).
  • Ensure that responses to regulatory inquiries are conducted in accordance with regulatory guidelines and in consideration of business implications.  


BS/MS in Chemistry.  


Experience & Skills Required

  • Minimum 3 - 5 years of pharmaceutical experience in an R&D analytical laboratory supporting small molecule, protein and peptide development programs.
  • Strong analytical skills, proven experience in wet chemistry, HPLC, Dissolution, KF, GC and spectrophotometry. 
  • Thorough knowledge of cGMPs, compendia requirements, FDA and EMA regulations. 
  • Experience working with and interpreting regulatory documents such as CFRs, FDA and ICH Guidance documents.
  • Excellent written and oral communication skills with an ability to prepare and present concise, technical data reports to non-scientific counterparts.
  • Prior experience with FDA/EMA inspections and audits a plus.
  • Proficiency in standard office software (MS Word, Excel, PowerPoint).
  • Must be detail oriented and organized with excellent documentation practices.