Title Analytical Scientist
Categories Career
Job Summary

Job Summary

We are seeking analytical Scientists to join our Analytical R&D team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation development by performing method development, validation, writing protocols and reports, conducting chemical and physical testing activities for both ANDA and NDA projects.

 

 

Responsibilities

Responsibilities

  • Develop and evaluate analytical test methods for raw materials and in-process and finished products
  • Write protocols and reports.
  • 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 approved test methods
  • Effectively communicate with cross functional teams like Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
  • Attend SOP, Safety and scientific training’s to remain current with cGMP regulations, and safety standards
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned
Qualifications

Qualifications:

  • Ph. D. in Chemistry or related majors with 0-3 years of experience, or a MS degree with 2+ years of experience, or a BS with 5+ years of experience is preferred.
  • Good understanding of chemical and physical analysis principles, experience in method development is preferred.
  • Fundamental understanding of GMP, ICH and FDA compliance is preferred
  • Excellent written and oral communication skills and interpersonal skills
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