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Product Development Principal Scientist

2 months ago

Trenton, New Jersey, United States Prinston Pharmaceutical Inc Full time

Job Summary

Prinston Pharmaceutical Inc. is seeking a highly skilled Senior Product Development Scientist to support its product development efforts in the R&D innovation pipeline. The ideal candidate will have a strong background in formulation and process development, with expertise in conducting literature and patent searches, applying Quality-by-Design (QbD) principles, and leading the planning and execution of scaling and submission batch manufacturing efforts.

Key Responsibilities

  • Conduct and/or lead formulation and process development for new drug products, including immediate release and modified release of oral tablets, capsules, and injectables.
  • Conduct literature and patent searches to support regulatory submissions of ANDAs and 505(b)2 NDAs.
  • Apply QbD principles to product development, including planning, designing, and conducting formulation and manufacturing process experiments.
  • Collect, analyze, and interpret experimental data, draw relevant study conclusions, and perform critical project data assessment.
  • Develop study reports and relevant chapters of regulatory submission.
  • Conduct manufacturing process scale-up and optimization, and lead the planning and execution of scaling and submission batch manufacturing efforts.
  • Interact with raw material manufacturers and equipment vendors to fulfill product development requirements.

Requirements

  • A MS or Ph.D. degree in Pharmaceutics, Pharmaceutical Engineering, Chemistry, Chemical Engineering, or a relevant scientific field.
  • Candidate with pharmaceutical industry experience is preferred.
  • Working knowledge of pharmaceutical processing and cGMP for various pharmaceutical dosage forms.
  • Practices safety in the laboratories.
  • Hands-on skills in fluid bed pellets coating process and top-spray granulation is a plus.
  • Strong verbal and written communication skills.
  • 10+ years of experience.

Benefits

  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Work Environment

  • Monday to Friday
  • Supplemental pay types: Bonus pay
  • Ability to commute/relocate: Somerset, NJ: Reliably commute or planning to relocate before starting work (Required)