ANGLE is a world leading and growing liquid biopsy company that develops products for use in rare cell diagnostics that enable early, accurate identification of an individual’s condition for the prevention, treatment, and monitoring of disease.
ANGLE’s research and development facilities in Guildford, UK are looking for a Product Development Programme Manager.
This position plays a crucial role in managing the NPD process across all R&D Projects, working closely with individual Project Managers and Programme Coordinators to ensure planning (based on regulatory and commercial/consumer requirements/needs), risk management, quality, milestone delivery, time and budget, with a predominant focus on meeting market and technical specification, ensuring regulatory approval, and optimising commercial value.
The job holder will be working closely with the senior management team to drive and steer the implementation of the strategic plan within the accepted timelines, budgets and resources, at the required quality level, identifying, resolving and escalating resource issues, avoiding technical, strategic and operational problems by proactively identifying and managing potential risks to the programmes.
- Responsible for achievement of QCD (Quality, Cost, Delivery) metrics for all projects.
- Oversee project teams in a matrix structure across molecular biology, cell biology, engineering, software, quality, regulatory and manufacturing.
- Manage the New Product Development Procedure and provide documentation and supporting evidence to ISO13485 and 21CFR820 standard.
- Implement Project Management procedures and metrics to monitor and mitigate risk and to ensure product deadlines are met.
- Communicate programme/project status and plans to senior management.
- Identify and drive countermeasures in instances when projects are off-target, overdue or exceeding budget.
- Establish and monitor use of visual tools for project tracking and management.
- Forecast staffing requirements.
- Provide the main interface between product development and operations and managing technology transfer and supporting manufacturing scale up.
- Manage Relationships with external organisations and collaborators as required.
- Undertake additional ad-hoc tasks as required.
Qualifications, Experience, Knowledge and Attributes:
- Minimum educational requirements are a master’s level qualification (Ph.D. preferred) in the life sciences or biochemical engineering, with at least 5 years post-graduate experience in a project management position specifically related to Healthcare systems, ideally in the in vitro diagnostics industry in diagnostic assay development/validation, or an equivalent combination of experience and formal education.
- At least PMP or PRINCE2 Certified (PgMP and/or PRINCE2 practitioner preferred).
- At least 5 years of experience in Technology Programme Management specifically related to Healthcare systems, ideally IVD products.
- Experience of managing people working in multi-disciplinary project teams, including management of contract R&D, in line with structured new product development processes.
- In depth knowledge of Medical Device regulations and standards including, but not limited to, 21 CFR 820 QSR, ISO 13485, ISO14971, IVDD, IVDR, GMP, GLP.
- Experience and skill in identifying when projects are overdue or exceeding budget, and demonstrable mitigation of such events.
- Experience of deploying visual tools for project tracking, issue identification and management.
- Demonstrated ability to manage teams by influence and displayed leadership skills.
- Experience of developing technical roadmaps to support product portfolio growth.
As a member of our excellent and fast-growing team you will receive opportunities for development and a competitive benefits package.
Salary estimate – £competitive
Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs.