This role requires regular on-site presence at our Fordham site, but we can offer flexibility for home working depending on business needs and priorities. Hybrid working arrangements can be discussed during the interview stage

Responsibilities

· Lead the Immunoassay Method Development team in Fordham; ensure best practices are applied across all method development activities

· Line management, coaching and mentoring the Principal Scientists[RS1]

· Core member of the Bioanalysis leadership team to set the strategy and direction of the department

· Provide oversight of all active method development projects across Immunoassay Bioanalysis, ensure projects are progressing to client requirements and expectations

· Drive the method development strategy, ensuring methods in Immunoassay are developed in the most efficient way

· Has overall responsibility for ensuring methods developed within the Immunoassay group are robust and fit-for-purpose

· Work with the method development team to provide robust, independent scientific review of bioanalytical methods following both method establishment and method validation ensuring methods are of good quality before they progress to the next stage

· Review method performance data and drive improvements as appropriate

· Deliver scientific training within the group and present internally on best practices

· Work closely with Bioanalysis colleagues to ensure delivery of high quality data to customers

· Contribute to the global scientific leadership team to set the direction on technological strategy, laboratory best practices, scientific training approaches, knowledge sharing and advising on best scientific solutions for customers

· Provide scientific support to the Business Development team; review customer requests and advise on feasibility

· Deliver scientific presentations to customers, support BD at customer meetings, lead scientific marketing initiatives and help develop new business[RS2]

· Build personal reputation within the industry

· Enhance Resolian reputation via conference presentations and publications in peer-reviewed journals

· Promote strong scientific collaboration both within Resolian and externally with industry and academic partners

· Ensure an up to date and appropriate scientific training programme for all scientists within Immunoassay teams and support the training programme of the wider bioanalysis department

· Contribute to a culture of continuous improvement to promote efficiency within the Immunoassay section and the wider department

· Be familiar with, and work to the Resolian Health and Safety Policy relevant to your role, paying particular attention to COSHH in the laboratory

Specific responsibilities

· Act as GLP Facility Management

Skills, Education & Qualifications

· Minimum of a relevant degree and at least 10 years’ direct experience is required within a senior scientific position within biotech, pharma or CRO industry

· Knowledge of method development of Immunoassays for PK, ADA and PD analysis

· Experience of coaching and leading scientific teams both through direct reports and within project teams

· Familiarity with GxP environments (specifically GCP and GLP) and an understanding of regulatory requirements (ICH M10 etc)

· Demonstrable experience in communicating complex science to clients, regulators and internal stakeholders

· Proven track record of presenting, publishing and involvement in the wider scientific community

Preferable skills and experience

· PhD in an appropriate subject.

· Experience and knowledge in cell and gene therapy

· Understanding of the whole drug development pathway

· Experience of the regulatory process for new chemical or biologicals approval