Arx Pharmaceutical Project Manager

Job Summary:

· Manages day to day activities for exciting pharmaceutical customer projects from early stage development through commercialization, serving as the primary liaison between customers and the internal team. Performs and assists the Director of Project Management in continuously improving ARx’s Product Development Process and project management best practices to bring pharmaceutical products to market and to help manage product and process changes to improve products already on the market. Works with the Project Team to create new Work Plans, using the Product Development Process structure, to outline the scope of work and budget for each customer / project. Responsible for making sure timelines are met and project scope defined in the Work Plan is maintained. Leads internal and customer facing meetings and follows up with team members to ensure the project moves forward. Performs the coordination functions essential to execute timely order entry and invoicing for those Work Plan and commercial activities.

Essential Functions:

Acts as a liaison between the customer and ARx for developmental and commercial projects, assures the timely completion of project activities, deliverables and shipments. Responsibilities include:

· Manages project team expectations and communications, hosting internal and external meetings, and providing timely agenda and meetings notes. Clearly communicates with team members to assure project needs, action items, and responsibilities are articulated and understood; monitors and facilitates progress; identifies and communicates project risks.

· Manages projects timelines, cost, business and quality objectives for multi-million dollar programs; communicates with management on a regular basis regarding status and timing for projects.

· Assures project plans, templates, and design records are assembled, complete, and kept up-to-date with ARx’s Product Development Process, accurately representing project history & status. Makes continuous improvement recommendations to Product Development Process.

· Identifies critical commercial program issues and drives open action items to resolution, with excellent communication skills, ensuring the best interests of ARx and the customer.

· Manages the initiation and closure of deliverables and shipments, ensuring on time completion. Receives Purchase Orders to start and performs invoicing functions upon completion.

· Gathers scope of work for Work Plans activities against ARx’s Product Development Process for new projects and out of scope activities. Prepares, coordinates and maintains record of Work Plans, quotations, and exhibits.

· Enters all purchase orders into Oracle system; reviews and verifies accuracy of pricing information against Supply Agreement or Work Plan. Confirms orders placed in accordance with Terms of Work or Supply Agreement.

· Manages invoicing and monitors receivables (coordinating with Finance & Administration Functions). Communicates forecasted revenue to upper level management.

· Assist Director of Project Management in other project management and pharmaceutical development initiatives as requested.

Additional Responsibilities:

· Contributes to the annual strategic planning process as requested.

· Follows all cGMP requirements and procedures specified for the position.

· Works with Quality group, Engineering Group, Operations Group, and Director of Marketing and Business Development to develop and revise applicable SOP's for position.

· Participates in and provides input to 6S/Lean or other operational initiatives.

· Works with other functional units to ensure identification of and compliance with best practices across project management, pharmaceutical development and business functions.

· Applies company policies, ensures good housekeeping, and enforces safety regulations.

· Performs other duties and responsibilities as assigned.

Job Specifications:

· > 5 years of project management, account management/ or pharmaceutical development or manufacturing experience preferred; college bachelor’s degree required, a science, engineering or business related field preferred; Project Management Professional certification advantageous.

· Ability to maintain confidentiality of customer, company, and products.

· Functioning capability with standard office software (video conferencing, word processing, spreadsheets, etc.).

· Ability to work independently with minimal supervision.

· Ability to comprehend and conform to ARx Quality Systems and cGMPs as outlined in 21CFR Part 211.

· Familiarity with standard project management and scheduling concepts, programs, practices, and procedures.

· Strong oral and written communication with an emphasis on strong interpersonal skills.

· Ability to accurately calculate and report financial information.

· Problem-solving and critical-thinking capabilities, particularly in managing and executing multiple, competing priorities.

· Capable of performing a variety of complex tasks with a certain degree of creativity and latitude.

· Ability to periodically travel to customers as required.