Prinston Pharmaceutical Inc.
Product Development Principal Scientist
Prinston Pharmaceutical Inc., Trenton, New Jersey, United States,
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
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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
#J-18808-Ljbffr