New Product Introduction Project Manager

Project Manager - NPI

Purpose

This role will support the External Supply Operations organisation by leading NPIs and coordinating product transfers into the external manufacturing network, as well as advancing systems and processes related to Site Selections, Launches, and Technical Transfer Management. This person will lead efforts that focus on joint team engagements, identifying and delivering on key project milestones, integrate external supplier functions with company processes, provide recommendations to drive pivotal initiatives, business performance and operational improvements. The Manager is responsible to stay informed of standard methodologies and provide innovative, impactful ideas to optimize processes to support the organisation’s growth strategies.

Responsibilities

•Responsible for leading new product introduction activities for new launches or programs tech transferring into CMOs

•Provide strategic direction of external manufacturing technical transfer and new product introduction activities coordinating execution of cross-functional workstreams from Quality, Process Development, Contracts, Supply Chain, Analytical Sciences and Global Strategic Sourcing.

•Execution and adherence to PSM NPI business processes and operating model

•Strong interpersonal skills as interactions will be both internal and external facing with CMOs and Executive leadership.

•Lead multiple cross-functional projects of medium to high complexity.

•Build and maintain project plans and team assignments using project planning tools, estimating project cost and adhering to budget, directing and supervising work efforts on daily basis, identifying resource needs, performing project reviews, and advancing functional, quality, timeline and cost issues appropriately.

•Understand and react to project risks, scope changes, industry trends and influences.

•Utilize project management processes, software and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.

•Handle communication with all areas of the enterprise that impact scope, budget, risk and resources of the work being managed and provide project updates and reporting to executive leadership and internal partners.

Qualifications

•Doctorate degree OR Master’s degree and 2 years of solid experience within a cGMP manufacturing or quality environment OR Bachelor’s degree and 4 years of solid experience within a cGMP manufacturing or quality environment OR Associate’s degree and 10 years of solid experience within a cGMP manufacturing or quality environment manufacturing or quality environment

•Strong organizational and cross-functional project management skills

•Strong technical background with understanding of pharmaceutical manufacture and commercialization

•Demonstrated accountability to deliver results and meet deadlines while handling contending priorities

•Problem-solving, critical thinking and decision-making skills

•Strong interpersonal, listening and customer service skills

•Experience managing and influencing in a matrix organization

•Manufacturing and cGMP knowledge and experience

•Strong negotiation skills

•Operational Excellence proficiency

•Understanding of contractual requirements

•Technical writing and multi-level presentation skills

•Experience leading effectively in collaborative team environment

•Proficiency in Microsoft Office especially Project, Excel, PowerPoint, Visio, Smartsheet and ThinkCell