Senior Analytical Scientist

Title: Senior Analytical Scientist

Job Summary

Support formulation development by performing analytical method development, validation, write and review protocols and reports, conducting testing in analytical method development and validation activities to support product formulation development, product technical transfer, method life cycle management, method troubleshooting and investigations, train and supervise junior level Analytical Chemists and Scientists, investigate deviations, OOS and OOT results, serve as analytical lead for projects, serve as analytical point contact person for clients.

 

 

Responsibilities

  • Lead analytical activities for assigned projects
  • Be the point person to communicate analytical matters to clients
  • Develop and evaluate analytical test methods for raw materials and in-process and finished products
  • Write and review protocols and reports, SOPs and other analytical-related documents
  • Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, stability samples to support new product formulation development for both ANDA and NDA projects
  • Conduct and document method verification and method validation as per approved method validation protocols, Company SOPs, FDA Guidance and ICH Guidelines
  • Conduct and document in-process and finished product testing for product release and stability as per the approval test methods
  • Effectively communicate with cross-functional teams such as Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
  • Attend SOP, safety and scientific trainings to remain current with cGMP regulations and safety standards
  • Follow relevant Frontida SOPs and FDA/ICH guidance
  • Other duties as assigned

Knowledge and Skills

  • Ph.D in Chemistry or related major with two years’ experience, or an Master’s Degree with five years’ experience or a Bachelor’s Degree with eight+ years’ experience
  • Good understanding of chemical and physical analysis principles, experience in method development is preferred
  • Fundamental understanding of GMP, ICH and FDA compliance
  • Excellent written and oral communication skills and interpersonal skills
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