Director, Formulation Development (Job Code: FD)

• Lead drug product formulation development for generics as well as innovative
• Lead all aspects of formulation development team at Primera including staff hiring and development, daily operation and compliance, budget and expense tracking, regulatory strategy, submission management and client interaction as well as team development
• Provide scientific and related regulatory expertise regarding formulation development ranging from generics reformulation, preclinical to clinical research phase as well as other late-phase formulation development NDA/ANDA/505b(2) to seek regulatory approval
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Interact closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements
• Write and review relevant reports for ANDA/IND/NDA applications Support business expansion with existing customers and broaden the customer basis by participating strategy development and business development activities (with respective business units)

Requirements:

• PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 years’ experience in pharmaceutical industries
• 3+ year experience in leading generics reformulation especially modified/extended release dosage forms with demonstrated successful ANDA or 505b(2) filing
• Innovative small molecule formulation development with demonstrated successful IND or NDA application filing highly desirable
• Excellent communication skills (oral, written, presentation), strong project management, team management and demonstrated problem solving skills
• Good knowledge of cGMPs, ICH guidelines, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, EMA/FDA CMC guidance documents will be an advantage
• Ability to work in a fast-paced, dynamic, environment