ASD Project Leader

Job Purpose

 

Lead and manage multiple in-house and/or 3rd party iSYS product development projects across IDS sites to obtain product/solution/services within specifications, at cost, and on availability targets.

 

Principal accountabilities and deliverables

 

Product development project leader is accountable for:

  • Design, develop and optimize immunoassay on automated systems through all phases of product development
  • Define project scope with project sponsor and product manager (reflected in Business plan, User needs, Design Inputs)
  • Manage the timelines for all activities, and for project tasks until project end (Design and development plan and detailed project plan, status reports)
  • Management of human resources required for the project, Manage R&D laboratory and department activities
  • Perform design and development risk assessment
  • Management of quality Ensure quality of project team outcomes and regulatory compliance
  • Communicate effectively and ensure the project follow up to the project team
  • Support project procurement (early detection of deficits and supply agreements for rare materials and reagents)

 

Product development project leader’s tasks and deliverables:

 

  • Develop conjugates, formulations, assay protocols, SOPS together with the functional experts assigned to the project team
  • Elaborate and implement work breakdown structure and tasks for the detailed project plan completing the default standards
  • Lead cross-functional project team, continuously define and get the knowledge and functional contributions from Product Manager, Core Tech, SIG, VAS/QC, manufacturing, RA, QA, Project Manager
  • Implement co-operation lines with external partners/3rd parties (if required)
  • Supervise on time availability of materials and reagents, especially appropriate samples
  • Prepare customer feedbacks, alpha testing, and clinical evaluation together with PM
  • Coordinate contributions of co-operating functional units and 3rd parties and capture aligned tasks in a cross-functional project plan
  • Plan, execute and supervise all product development tasks covered by the project plan
  • Lead, motivate, inform and integrate project team, staff, and partners
  • Supervise assigned staff for effectiveness to utilize tools, methods, equipment
  • Elaborate, complete and communicate project documentation compliant with regulations. (including minutes, reports. DHF and TF)
  • Ensure compliance with methodologies and regulations.
  • Quantify human resources related, direct project cost, and Capex requirements necessary to keep project on target
  • Prepare, document and follow up design review and project milestones
  • Attend/present scientific events and conferences relevant to the projects and prepare posters and customer information

 

Skills, Knowledge, and Experience

 

Qualifications

 

  • Bachelor degree in Science; Higher degree MSc and or Ph.D. -but not essential
  • 8+ years relevant related professional experience ideally gained within Immuno Assay Development for automated systems across various disciplines
  • 5+ years people management experience including leading cross-functional teams
  • Strong and proven experiences in business Project Management and Change Management

 

Skills & Knowledge

 

  • Proven track record to manage programs and projects in global organizations across distance, culture, and technology
  • Proven capability to enable leadership in complex situations
  • Proven track record on realization of design to cost product lines and products
  • Excellent communication skills, negotiation skills and conflict management skills
  • Proficiency utilizing MS Office tools and portfolio/project management SW solutions
  • Fluent in English, French is highly beneficial, further languages are beneficial
  • Comprehensive knowledge of relevant biochemical methods and technologies
  • Thorough knowledge of regulatory requirements for new products.

 

Experience

  • Coaching of project teams in integration management, change management, program management
  • Build efficient and strong relationships with business project stakeholders, and project portfolio stakeholders, functions and project leaders/teams
  • Strong collaborator who can work efficiently with other in matrix environment, knows how to use formal and informal networks to drive timely and measurable results
  • Ability to influence with and without authority Strong experiences in developing and delivering training and coaching for individuals/teams
  • High cultural awareness and proven ability to work with a wide range of cultures
  • Ability to work cross-functionally across multi global sites

 

Cultural Aspects

 

  • Passion for Customers – We are passionate in understanding our customer needs and dedicated to providing excellent solutions
  • Entrepreneurial – We consider the world around us as a set of opportunities, creating the chance to innovate and find solutions to generate customer and stakeholder value
  • Excellence – We strive for excellence in all we do, to deliver the best results in order to be best in class!
  • Respect – We show consideration for colleagues, customers and all business stakeholders, appreciating our diversity and respecting each other’s opinions
Job Role ASD Project Leader
Job Department Research and Development
Job Region Boldon - UK
Job Country UK