What are the responsibilities and job description for the Director of Product Development position at Prinston Pharmaceutical Inc.?
About the Company :
Huahai US, together with its subsidiaries Prinston Pharmaceutical, Solco Healthcare, and Prinston Labs, are focused on the development, manufacturing, and marketing of generic pharmaceuticals. With a diverse range of generic prescription products in therapeutic categories like cardiovascular, central nervous system, anti-infectives and pain management, we strive to meet the healthcare needs of our customers. With a robust pipeline of potential new products and adherence to FDA regulatory standards, we manufacture our high-quality products in state-of-the-art GMP facilities both in the US and overseas. In addition, we own an R&D facility in Somerset, NJ, and a manufacturing facility in Charlotte, NC.
Position :
Director of Product Development
Prinston Pharmaceutical Inc. is looking for a qualified candidate with pharmaceutical industry experience to take on the role of Director of Product Development to support its product R&D efforts.
Key responsibilities :
1. Lead the Product Development (PD) department to develop new pharmaceutical products in the R&D product portfolio from project kickoff through commercialization. Activities include but not limited to :
- Leverage understanding of the scientific principles of pharmaceutical sciences to design and develop finished dosage forms and manufacturing process to achieve product development goals. At the current stage, the products are primarily generic drug products (ANDAs).
- Guide formulators to conduct literature search, formulation and manufacturing process development for new ANDA products following QbD principles.
- Review data, scientific literature and provide directions and solutions to solve product development problems.
- Work closely with analytical R&D counterpart to ensure that all methods development, brand drug product characterization studies, prototypes quality and stability testing, and establishment of product quality specifications are carried out in a timely manner to support successful new ANDA product development.
2. Provide leadership in technology transfer, manufacturing process scale-up and submission batch manufacturing.
3. Support ANDA filing and Post-Approval Supplement initiatives.
4. Lead and manage the control substance program at the Prinston Pharmaceutical R&D laboratories
5. Manage the Product Development Laboratory
6. Mentor and manage direct reports including handling their objectives setting and performance reviews.
7. Provide scientific and technical input for new product evaluation to support Portfolio Management.
Requirements
Benefits :
