Senior Manager, NPI Lead

This is what you will do:

The New Product Introduction Lead is responsible for the program management in terms of scope, budget, schedule and quality delivery for the technology transfer, capital equipment requirements and operational readiness to enable the introduction of new products for manufacture within the existing College Park Manufacturing Facility.  Primarily focused on large molecule commercial bulk drug substance NPIs, the role will in future also support project management of fniished product including medical device assembly, and clinical as well as commercial transfers.  The role is responsible for ensuring the program meets safety, technical, and quality requriements as set out for the project as well as delivering the schedule and cost related objectives.

You will be responsible for:

Responsible for the project management of NPI/Technology Transfer of products to the College Park site.  This includes oversight of the full lifecycle of the NPI, coordinating and rogressign through all stagegates from initial planning and business case development, feasibility assessments, basis of design, capital approval, project delivery up to and including commissioning validation, PPQ and inputs into regulatory submission. Responsible for ensuring that the Alexion business needs and priorities are clearly understood incorporated and communicated throughout, and generating and delivering an execution plan that reflects the scope and schedule required to meet these needs and priorities.

• Reporting to the head of Technical Operations, the NPI Lead will collaborate with project team members from Manufacturing Operations, Technical Services, NPI Quality, QC, Alexion Technical Operations, Strategic sourcing, process development and clinical supply (PDCS), and Regulatory/CMC, 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.
• Plan and execute multi-discipline Tech Transfer projects, including project approach and resource needs, options analysis, through the project delivery phases.
• Safety: Ensure that the capital project elements are planned and executed in accordance with site safety policies and procedures and that the manufacturing process being transferred is fully risk assessed and implemented in a safe manner in terms of procedural, automation and new raw materials are reviewed collectively an meet all safety requirements during commissioning and sustaining manufacturing. 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 Alexion 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 withn technical services and the relevant sending unit.
• 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.
  

You will need to have:

• Experience in pharmaceutical manufacturing, preferably biopharmaceutical  (large molecule) Bulk Drug Substance (BDS) manufacturing.
• 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.
• 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 of using Lean or six-sigma tools would be advantageous.
• Minimum undergraduate degree or equivalent (QQI level 8) in science or engineering.

We would prefer for you to have:

• Project Management qualification (e.g. PMP or Masters in a business related discipline)
• Technology transfer experience.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.