Career Opportunities
Department: Pharmaceutical Sciences
Job Title: Director Pharmaceutical Sciences
Description:
The Director of Pharmaceutical Sciences will be responsible for developing technical strategies and managing work activities necessary for the development and manufacture of Neurogesx’ products. The director will be responsible for managing and oversight of API and Drug product process/product development, clinical and commercial manufacturing activities. A key responsibility will be to cultivate and maintain productive relationships with external CMO contractors as well as with internal corporate compliance and regulatory functions. In additional, this position will be responsible for draft and review of CMC section of IND’s & NDA’s and other regulatory communications.
Essential Functions:
- Develop project strategy and manage work projects, protocols, procedures, batch records.
- Coordinate cost quotations, work scope and protocols with CMOs
- Coordinate completion of studies against corporate goals and timelines
- Manage progression of development drug candidate into commercial production
- Designs, implements and interprets scientific studies to provide sound technical information to other functional areas and corporate partners
Job Requirements:
- Thorough understanding of scientific and technical principles applied to pharmaceutical product development and manufacturing processes
- Knowledge of API manufacturing and Drug Product including Formulation/Drug Delivery Systems is essential
- Fluent knowledge of cGMP guidelines required
- Experience with CMO contract development and manufacturing. Foreign CMO management experience recommended.
- Comfort with a small company environment
- Good communication, writing and interpersonal skills
Education:
PhD in relevant pharmaceutical science or related field with a minimum of eight years of relevant experience, or MS/BS in pharmaceutical science or related field with a minimum of ten years of pharmaceutical development and manufacturing experience.