Title: Associate Analytical Scientist
We are seeking an Associate Analytical Scientist to join our Analytical Research & Development 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.
- 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
- Participate in analytical method development
- Conduct and document method verification, method transfer, and method validation as per approved method validation protocols, Company SOPs and ICH Guidance
- 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 trainings to remain current with cGMP regulations, and safety standards
- Follow relevant Frontida SOP’s and FDA/ICH guidance
- Other duties as assigned
Knowledge and Skills
- Master of Science in Chemistry or related major with 0-2 years’ experience or a Bachelor of Science degree with 0-3 years’ experience is preferred
- Experience with generic drug analysis is desirable
- Good understanding of chemical and physical analysis principles, knowledge and experience in chromatography analysis, UV, IR, and dissolution
- Fundamental understanding of GMP, ICH and FDA compliance
- Good written and oral communication skills and interpersonal skills.