Demo

Method Development Engineer - validation

Consumer Product Partners
Smyrna, TN Full Time
POSTED ON 2/18/2025
AVAILABLE BEFORE 5/17/2025

Company Overview : We are an OTC Drug and Cosmetics manufacturer with an Employee Stock Ownership Plan (ESOP, seeking a dedicated and experienced Analytical Chemist / Methods Engineer to join our team.

Key Responsibilities :

  • Design, develop, validate, and verify analytical methods for testing raw materials, finished products, stability, and process validation.
  • Conduct analysis of Active Pharmaceutical Ingredients (APIs), excipients, and finished drug products according to company SOPs, cGMPs, GLPs, GDPs, and FDA / DEA / OSHA regulations.
  • Develop and execute protocols, reports, and test methods related to raw material and finished product testing.
  • Provide technical expertise to support laboratory investigations and method transfers between facilities.
  • Operate and troubleshoot routine laboratory equipment, including Gas Chromatography (GC), Liquid Chromatography (LC / HPLC / UPLC), and Inductively Coupled Plasma (ICP).
  • Utilize Empower software for data analysis and method development.
  • Ensure compliance with FDA Regulations, USP / NF monographs, and ICH guidelines.

Required Qualifications and Skills :

  • BS degree in analytical chemistry, organic chemistry, biochemistry, or food science with coursework in analytical chemistry.
  • Minimum of 3 years of laboratory experience in method development, validation, verification, and transfer activities for pharmaceutical raw materials and finished products.
  • Proficiency in operating laboratory instrumentation and conducting statistical analysis.
  • Strong knowledge of USP, FDA, and ICH guidelines.
  • Effective communication skills and ability to work independently with minimal supervision.
  • Proven ability to organize projects and complete tasks in a timely manner.
  • Preferred Skills :

  • Proficiency in Empower software.
  • Self-motivated with the ability to work independently and within a team.
  • Strong organizational skills and attention to detail.
  • Education :

  • Minimum requirement of a BS degree in analytical chemistry, organic chemistry, or biochemistry.
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