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R&D Sr. Scientist

3 months ago

Cranbury, United States Medix™ Full time

Responsibilities

  • Develop and optimize analytical methods for various dosage forms (tablets, capsules, solutions, suspensions) independently
  • Methods may include Assay, Impurities, Dissolution, and Residual Solvents analysis
  • Provide analytical support to Formulation Development by conducting experiments (assay, impurity testing, dissolution)
  • Utilize advanced instrumentation such as LC, GC, UV/VIS spectrophotometry, FTIR, dissolution testers, pH meters, and other wet chemistry techniques
  • Take ownership of method validation, verification, and transfer activities
  • Ensure compliance with regulatory requirements
  • Author and meticulously document method validation, verification, and transfer protocols and reports
  • Follow good documentation practices
  • Accurately record experimental results, analyze data, and generate comprehensive reports
  • Effectively communicate findings and contribute to decision-making processes
  • Act as a mentor to junior scientists
  • Provide guidance, training, and support in their professional development
  • Collaborate with cross-functional teams (Formulation Development, Quality Assurance, Regulatory Affairs) to ensure timely and successful project outcomes
  • Perform additional tasks or projects assigned by management to support analytical R&D objectives


Requirements

  • Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field
  • Extensive hands-on experience in developing and validating analytical methods for pharmaceutical dosage forms (tablets, capsules, solutions, suspensions)
  • Proficiency in using a wide range of analytical instruments and techniques (LC, GC, UV/VIS, FTIR, dissolution testers, pH meters)
  • Strong knowledge and expertise in method validation, verification, and transfer processes
  • Excellent understanding of regulatory guidelines and requirements related to analytical method development and validation (e.g., FDA, ICH, USP)
  • Demonstrated ability to author method validation protocols, reports, and other scientific documents
  • Excellent record-keeping skills, attention to detail, and adherence to good documentation practices
  • Proven ability to work independently, manage multiple projects simultaneously, and meet deadlines
  • Strong communication and interpersonal skills for effective collaboration within cross-functional teams
  • Previous experience in mentoring and training junior scientists is preferred