11756694 – Program Manager (NPI) – Dublin Contractor

Purpose:

The role of New Product Introduction (NPI) Manager is responsible for the program management of overall scope, budget, schedule and quality delivery for the Technology Transfer and introduction of new products, drug substance, drug product, finished product or combination product, either to an internal site or an external CMO site to ensure the program meets Business, Technical, and Quality objectives as set out for the
project.
Reporting to the head of Global Engineering, the NPI Manager will collaborate closely with Technical Operations, Supply Relationship Management, Quality, External Plant Operations, Product Development, Regulatory Affairs and the external CMO to plan and execute a multi-discipline Tech Transfer project, including project approach and resource
needs, options analysis, schedule, budget and ownership throughout the project delivery phases.

Responsibilities:

• Responsible for the program management of NPI/Technology Transfer of products across the manufacturing network, from initial planning to regulatory filing.
• Ensure that the business needs and priorities are clearly understood and that the program execution plan reflects the scope and schedule of these needs and priorities.
• Plan and execute multi-discipline Tech Transfer projects, including project approach and resource needs, options analysis, through the project delivery phases.
• Develop project controls (plan, integrated schedule, risks and cost) to ensure alignment of project timelines and budgets with business needs.
• Communicate progress against plan on a regular basis. Prepare monthly metrics on program performance, achievements, and statistics. Ensure appropriate internal and external communication is established and maintained throughout the program execution.
• Ensure all applicable policies, guidelines, and procedures are followed in the compliant execution of construction and start-up activities.
• Provide support to Technical team creating project management reports/
schedules/plans etc.
• Organise and facilitate project meetings / Stage Gate meetings in conjunction with the TT leader.
• Ensure the appropriate resources are allocated to the project.
• Support the development of a lean and standardized approach and format for new product introduction that can be replicated and continuously improved for future product transfers.

Minimum Qualifications and Experience:

• Minimum undergraduate degree in science or engineering.
• Minimum 5 years experience in pharmaceutical manufacturing. Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and Aseptic Fill Finish is preferred.
• Strong track record of leading in a global and matrix environment and working cross functionally with internal and external stakeholders.
• Demonstrated leadership of technical and / or operational teams or projects within a pharmaceutical manufacturing organization.
• Experienced in Technology Transfer and new product introduction project work.
• A working knowledge of regulatory requirements for pharmaceutical industry is required.
• Ability to quickly establish strong, effective and enduring partnerships with internal and external stakeholders
• Strong organizational, change management, problem solving and leadership skills.
• Exceptional presentation and communication skills.
• Team player with the ability to manage multiple tasks simultaneously.
• Operational excellence knowledge and application using Lean or six-sigma tools would be advantageous.