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 |