Director of Laboratory Operations – Molecular Science

Director of Laboratory Operations – Molecular Science
Birmingham

Permanent

£ competitive, and commensurate with background, skills and experience
Role scope:

This is a newly created role developed to incorporate management of strategic teams of this high-growth-trajectory organisation. Core responsibility will centre around quality management, management of the lab operations, business support and order fulfilment of specialist molecular reagents.
You will have a background in managing diverse growing teams, thrive in an agile and demanding environment and bring significant industry experience from a molecular/IVD development background.

Role requirements:

• Accountable for the management and output of the production team, order fulfilment and business support functions
• Set and monitor short, medium and long-term objectives which measure both individual and team performance and allow for personalised development of those reporting to you
• Working closely with SLT in the strategic planning of business operations to ensure alignment of organisational objectives
• Development of budgets, monitoring, and setting expectations to achieve them
• Workforce and resource planning to ensure capacity to deliver on demand whilst not compromising on quality of output
• Responsible for Production, Business Support and Order Fulfilment in order that all teams can function effectively and comply with ISO 13485 quality standards
• Planning, execution and monitoring of operational standards to ensure quality, compliance and scheduling is achieved, including approval of controlled process documents relevant to manufacturing, IQC, risk management and health and safety
• Forecasting, demand planning and responsible for raw material procurement in order to fulfil production scheduling
• Continuous improvement of operational processes, review of quality, productivity, efficiency and analysis of KPI’s. Reporting data relating to these areas at SLT meetings in order to inform strategic planning
• Participate in internal and external lab audits in order to support regulatory accreditations
• Delivery of specialised training to staff, coaching and development – including customised training plans, provision of necessary materials and competency assessments
• Ownership of Tech Transfer of new products from the R&D process into production scale involving close collaboration with leaders from Product Development and R&D
• Taking an active and informative role in the product development lifecycle, including maximising ROI based on good supplier agreements, accurate tech transfer, bill of materials and manufacturing scalability are well evaluated and fit for purpose

Your background:

• Further degree in Science discipline such as Molecular Biology, Biotechnology, Genetics/Genomics or an Engineering-related field (MSc or beyond ideally) – or equivalent
• A demonstrable industry background, ideally from within a molecular IVD-based setting in which you have been responsible for operational management of both people and resources, quality standards and logistics
• You will have played a key role in obtaining and retaining ISO 13485 quality standard, and be well versed with the relevant regulatory requirements of this sector
• Significant practical experience of handling specialist molecular reagents, working to GLP
• Well-rounded hands-on experience of the technology which underpins areas of application for the business, including NGS, DNA/RNA extraction, PCR/rt/q
• Able to present complex technical concepts and data in an elegant and accessible manner, highly organised and able to pre-empt operational and resource needs
• Good working knowledge of ERP systems such as NetSuite, MS Office and order fulfilment packages
• Resilient, accustomed to working in an agile manner with frequently changing demands and with a high attention to detail – able to objectively interrogate data and processes to ensure best outcomes for the business