Product Development Principal Scientist - Prinston Pharmaceutical : Job Details

Job description

Product Development Principal Scientist

Job Type: Full-Time

Job Location: Somerset, NJ

Prinston Pharmaceutical Inc. is looking for a R&D Senior Product Development Scientist to support its product development efforts.

Key responsibilities:

• Conduct and/or lead formulation and process development for new drug products (i.e. immediate release and modified release of oral tablets, capsules and injectables) in R&D innovation pipeline.
• Conduct literature/patent search for pharmaceutical product development in support of regulatory submissions of ANDAs and 505(b)2 NDAs.
• Apply Quality-by-Design (QbD) principles to product development.
• Plan, design and conduct formulation and manufacturing process experiments; collect, analyze and interpret experimental data; draw relevant study conclusions; perform critical project data assessment; develop study reports and relevant chapters of regulatory submission.
• Conduct manufacturing process scale-up and optimization; lead the planning and execution of scaling as well as exert submission batch manufacturing efforts during product technology transfer from R&D to Production.
• 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 relevant scientific fields. 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/written communication skills.
• 10+ years of experience.

Pay: $95,000.00 - $125,000.00 per year

Benefits:

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

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Somerset, NJ: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Project management: 1 year (Preferred)
• Customer service: 1 year (Preferred)
• FDA regulations: 1 year (Preferred)

Work Location: In person