The incumbent reports to the Director of Project Management. He (or she) interacts with the team members and the department heads to ensure timely project completion. The incumbent will manage several projects at any given point in time. He/She will directly lead and manage teams consisting of individuals from a wide range of functional groups throughout the company including R&D, Technical Services, Portfolio Management, Regulatory Affairs, QA/QC, Supply Chain Operations, Marketing, Business Development, Legal and IP, and API Sourcing.
Essential Functions and Responsibilities
· The incumbent is responsible for the timely execution of all activities pertaining to projects assigned to him or her (project selection, API selection, product development, scale up, filing, validation and product launch).
· The incumbent’s main responsibility is to ensure timely execution of project deliverables. He/she will help the team overcome cross-functional hurdles. He/she will ensure timely identification and escalation/resolution of issues to achieve Division objectives.
· The incumbent will be familiar with a matrix management environment. The incumbent will help define clear roles and responsibilities for the organization.
· The incumbent will directly manage cross-functional teams (Formulation, Analytical Development, Technical Services, Manufacturing, Quality, Regulatory, Marketing and Legal) to ensure that department objectives (API selection, product development, ANDA filing, scale-up, product validation and launch) are met.
· The incumbent will have strong analytical and interpersonal skills. He/she needs to develop and maintain strong working relationships across all parts of the organization to facilitate timely and effective communication between the team members and line management.
· Possesses a basic understanding of generic and/or branded pharmaceutical product development from project inception through product launch, including knowledge of ANDA (or NDA) submission activities.
· Must understand the principles and practices of pharmaceutical manufacturing and pharmaceutical validation in the areas of manufacturing and analytical development.
· Demonstrates a high sense of urgency, and is capable of working with minimal direct supervision.
· Demonstrates a strong knowledge of project management principles; proven leadership ability; and proven interpersonal, communication, problem solving, presentation, and facilitation skills.
· Incumbent must be goal oriented, decisive, and able to demonstrate the ability to think strategically as well as tactilely with respect to pharmaceutical product, process and business development.
· Must demonstrate flexibility and versatility to manage complex interdisciplinary technical projects in the presence of changing priorities. Demonstrates the ability to manage multiple complex projects at any given time and to achieve deliverables and milestones in a timely, efficient manner.
· Incumbent should have a working knowledge in several of the following areas: GMP compliance, FDA ANDA filings, FDA NDA filings, regulatory affairs, quality assurance/quality control principles and practices, technical services activities, pharmaceutical commercial operations, and generic/branded drug development cycles.
Equipment and Applications
· Microsoft Project and other MS Office applications to include MS Word and MS Excel.
· Capable of learning new and advanced computer applications related to project management, database processing, and internet applications.
Work Environment and Physical Demands
· Ability to work in an office environment
· Ability to operate a PC
· Lifting; sitting
· BS degree in related field
Minimum of 7 years pharmaceutical (or related) experience.
· The incumbent should have experience in at least two different functional areas, Product Development (Analytical, Formulation, Process Development) and in an area in the Supply Chain (Quality, Operations, Technical Services, etc.).