New Product Introduction Project Manager

Tandem Project Management Ltd.; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Tandem Project Management Ltd. is assisting a global biopharmaceutical company based in Dublin in recruiting an NPI Project Manager.

The role covers project management and coordination for introducing new products within Bulk Drug Substance Manufacturing, overseeing scope, budgets, and scheduling to support technology transfer from a receiving site. You will coordinate multidisciplinary teams across Operations, Technical Services, Engineering, Validation, Automation, QC and QA to meet

Qualifications

• Degree or Master’s in a science or engineering discipline, or vocational qualification in NPI.
• Minimum of 5 years’ experience in pharmaceutical manufacturing (bulk drug substance biologics preferred).
• Minimum of 3 years’ Project Management experience leading cross-functional teams in pharma.
• Experience in Technology Transfer and/or New Product Introduction projects.
• Working knowledge of regulatory requirements for pharma.
• Operational Excellence experience preferred.
• Application of AI tools preferred.
• Lean or Six Sigma tools advantageous.

Responsibilities

• End-to-end PM and coordination of site activities for introducing new products, from feasibility to manufacture, regulatory filing and approval.
• Create and maintain a standardised work breakdown structure and project schedules for technical transfer and readiness from a receiving unit perspective.
• Support CMC sub-teams and Supply Chain NPI/Launch teams with progress updates, risks and mitigation plans.
• Provide direction to the internal NPI project team across disciplines to execute site activities.
• Plan and execute Technology Transfer projects, including resource needs and options analysis.
• Develop project controls: plan, schedule, risks and cost to align timelines and budgets.
• Communicate progress regularly and prepare dashboards on performance and costs.
• Ensure policies and procedures are followed during construction and start-up activities.
• Support the technical team with PM reports, schedules and plans.
• Organise and facilitate project meetings and Stage-Gate reviews with NPI Lead and CMC sub-teams.

Skills

Project management

Coordination

Cross-functional leadership

Regulatory knowledge

Operational excellence

AI tools

Lean or Six Sigma

Education

Bachelor's or Master's in science/engineering

NPI/Technology Transfer training

Tools

AI tools

Job description

Our client is a global biopharmaceutical company based in Dublin seeking an NPI Project Manager who will be responsible for project management and coordination, scope, budget development and monitoring, and scheduling for the introduction of new products within Bulk Drug Substance Manufacturing. The role has broad project management responsibility for coordinating all disciplines represented in the NPI team that are essential to successful Technology Transfer from a receiving site perspective. This includes multidisciplinary teams across Operations, Technical Services, Engineering/Capital Projects, Validation, Automation, QC and QA to meet business, technical, quality, safety, cost and supply-readiness objectives. The role will support clinical and PPQ supply readiness and regulatory submission and approval commitments to enable clinical and commercial supply for each new product.

Responsibilities:

• Responsible for the end-to-end project management and coordination of site activities to enable introduction of new products, from feasibility scenario assessment and initial planning through to manufacture, regulatory filing and approval.
• Create and maintain a standardised work breakdown structure and project schedules to align with and facilitate delivery of technical transfer and operational readiness requirements from a receiving unit perspective, according to relevant regulations, policies and procedures.
• Support CMC sub-teams and Supply Chain NPI/Launch teams as required, providing regular updates on progress, risks and mitigation plans as appropriate.
• Provide direction and coordination to the internal NPI project team comprising functional leads for each discipline as required to execute NPI site activities.
• Support planning and execution of multi-discipline Technology Transfer projects, including project approach, resource needs and options analysis through the project delivery phases.
• Develop project controls, including the 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 and prepare weekly and monthly dashboards using Smartsheet with metrics on programme performance, achievements, cost reporting and statistics.
• Ensure appropriate internal and external communication is established and maintained throughout programme execution.
• Ensure applicable policies, guidelines and procedures are followed in the compliant execution of construction and start-up activities.
• Provide support to the technical team in creating project management reports, schedules and plans.
• Organise and facilitate project meetings and Stage-Gate meetings in conjunction with the NPI Lead, Technology Transfer Leader and CMC sub-teams.
• Ensure appropriate resources are allocated to the project.
• Support the development of a lean and standardised approach and format for new product introduction that can be replicated and continuously improved for future product transfers.

Qualifications & Experience:

• Degree or Master's in a science or engineering discipline, or vocational qualification and/or training specific to New Product Introduction.
• A minimum of 5 years’ experience in pharmaceutical manufacturing. (5 years’ experience in Bulk Drug Substance Biologics product manufacturing would be preferred.)
• A minimum of 3 years’ Project Management experience leading cross-functional teams within the pharmaceutical industry.
• Experience in Technology Transfer and/or New Product Introduction project work.
• A working knowledge of regulatory requirements for the pharmaceutical industry is required.
• Operational Excellence experience would be preferred.
• Application of AI tools would be preferred.
• Application of Lean or Six Sigma tools would be advantageous.
• A project management certification is desirable but not required.