Senior Analytical Scientist

Philadelphia, PA

2 DAYS AGO

21718798

Summary

Philadelphia, PA

Competitive Salary

60 Months Experience

Bachelor's degree

No Commisssion

40.00 hours per week / Day Shift /Full-Time

Description

Lead analytical activities for assigned projects. Communicate analytical matters to clients. Develop, trouble-shoot, and validate analytical test methods for raw materials and in-process and finished products. Write, review, and approve protocols and reports. Prepare analytical related documents for NDA and ANDA submissions. Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, and 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. Attend SOP, safety, and scientific trainings to remain current with cGMP regulations. Follow relevant Frontida SOPs and FDA/ICH guidance.

Requirements:

Bachelor's degree in chemistry, pharmaceutical sciences, or a similar field, and five years of experience in analytical chemistry in a pharmaceutical environment.

Knowledge of chemical and physical analysis principles.

Experience in method development.

Fundamental knowledge of Good Manufacturing Practice (GMP), International Council for Harmonization (ICH), and Food and Drug Administration (FDA) compliance.