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Analytical/QC Research Scientist Drug Product/Drug Substance) (Cranbury)
Analytical/QC Research Scientist Drug Product/Drug Substance) (Cranbury)Porton Pharma Solutions Ltd. • Cranbury, NJ, US
Analytical / QC Research Scientist Drug Product / Drug Substance) (Cranbury)

Analytical / QC Research Scientist Drug Product / Drug Substance) (Cranbury)

Porton Pharma Solutions Ltd. • Cranbury, NJ, US
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Job Title : Analytical / QC Research Scientist

Location : Onsite, Cranbury NJ

Position Type : Full-Time

Reports To : Director, Analytical R&D / QC

Job Summary :

We are seeking a highly motivated Research Scientist to join our Analytical R&D and QC department within the CDMO (Contract Development and Manufacturing Organization) industry. The ideal candidate will have a strong background in analytical chemistry and experience in method development, validation, and quality control testing.

Key Responsibilities :

  • Conduct analytical method development and validation independently.
  • Troubleshoot analytical methods as needed and gain more experience in the related area.
  • Conduct release testing for GMP regulatory starting materials, intermediates, and final APIs.
  • Conduct testing for stability studies and cleaning verification.
  • Review test data to ensure completion and accuracy.
  • Write raw material test procedures as needed under supervision.
  • Write SOPs and protocols as needed under supervision.
  • Write instrument operating, maintenance, and qualification / calibration procedures as needed.
  • Participate in OOS and deviation investigations, as needed.
  • Support Quality Assurance as needed during internal audits and audits by clients and regulatory agencies. Assist in the development and implementation of corrective actions related to QC / AD.
  • Troubleshoot and maintain analytical instruments. Ensure that instrument calibration and qualification intervals are current.
  • Perform structural elucidation of small molecule drug substances, intermediates, and starting materials.
  • Independently troubleshoot and resolve issues with NMR instrumentation.
  • Provide clear oral and written explanations of NMR data for structural elucidation
  • Identify and elucidate the structures of related impurities and degradants from API synthesis, fate and purge, and stress degradation studies.

Qualifications :

  • BS, MS, or PhD in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related field.
  • 3+ years of experience in analytical R&D and / or QC within the pharmaceutical or CDMO industry.
  • Strong knowledge of analytical techniques, including HPLC, GC, UV-Vis spectroscopy, and dissolution testing.
  • Familiarity with method validation protocols and regulatory requirements.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
  • Proficient in data analysis software and laboratory information management systems (LIMS).
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    Research Scientist • Cranbury, NJ, US