Director of Product Development

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. Work closely with Technical Operations and Manufacturing team within Prinston Pharmaceutical and at CDMOs to conduct process scale-up studies and manufacturing of submission batches. Review/approve and supervise direct reports to review/approve batch records, protocols, in-process control/finished product specifications and reports for all products developed for ANDA filing with the FDA. 3. Support ANDA filing and Post-Approval Supplement initiatives. Guide formulators to draft relevant sections of the ANDA documents for filing with the FDA. Review relevant sections of the ANDA documents for filing. Provide inputs and organize studies to generate data needed for developing responses to address the FDA ANDA deficiencies. Provide inputs to support PAS initiatives for approved products led by Product Management. 4. Lead and manage the control substance program at the Prinston Pharmaceutical R&D laboratories Maintain control substance program status, including laboratory security, documents, and licenses related renews and updates. 5. Manage the Product Development Laboratory Ensure the safety guidelines are followed for all product development activities. Ensure the equipment capability and capacity are adequate and ready to support in-house product development projects. 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 • A self-motivated professional with strong verbal and writing skills who can effectively communicate with peers. • Ph.D. in Pharmaceutics, Pharmaceutical Engineering, Chemistry, Chemical Engineering, or other relevant scientific fields. • Oral solids dosage forms experience (i.e., immediate release, delayed release and extended release) required. Injectables and complex generic experience (i.e., injectables, topicals) are a plus. • Working knowledge of major pharmaceutical processing technologies and cGMP requirements for different pharmaceutical dosage forms. • DEA scheduled compound product development experience is a plus. Benefits: • Medical, dental and vision insurance. • 401k match.