Senior Technical Specialist

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Job description

My client is a fast-growing growing diagnostics biotech company specialising in infectious diseases, currently looking to bring on a Senior Technical Specialist to join their expanding Technical Manufacturing Team.

As a Technical Specialist, you will be responsible for activities such as leading product failure investigations, QC investigations, validation activities, identification and testing of product components, identifying and developing new manufacturing methods, approaches and processes and establishing and advising on appropriate product performance measurements.

Main Duties and Responsibilities:

* Independent project lead responsibilities e.g. investigations or process implementation
* Independent driving of projects and responsibility for project progress
* Using scientific knowledge to resolve technical manufacturing and QC issues
* Using scientific knowledge to provide expert technical support and problem solving for the manufacturing and associated teams
* Establish and maintain a continuous improvement cycle in the manufacturing processes
* Identify alternative raw materials, advise on the suitability of inclusion of raw materials and establish suitable testing methods to support implementation
* Establishing appropriate performance evaluation testing methods and criteria to support right first-time manufacturing and QC
* Identify process improvements to drive efficiency and accuracy
* Identify and develop alternative or novel methods for pre-existing processes
* Identify, develop, and implement new manufacturing methods to meet changing demands in either scale or new product implementation
* Serve as a scientific consultant for internal and external customer queries (Second line tech support)
* Presentation of work to management team\/key stakeholders
* Independent contributions to interdepartmental activities to ensure uninterrupted manufacturing and facilitate meeting business goals
* In depth knowledge of products being developed through R&D to enable efficient tech transfer support, manufacturing support and fault finding once in production
* Ensure the completion of documentation in line with an ISO13485 quality management system
* Training of manufacturing and technical team
* Identify products and processes with weaknesses to be included in trend analysis and performance indicator analysis.
* Track these analyses and proactively address changes in trends
* Lead product development activities with non-R&D driven solutions to achieve product realization
* Risk analysis
* SOP writing and review
* Report writing
* Participation in project and team meetings

Requirements:

* MSc\/PhD in a related Scientific field
* Extensive experience of working within a laboratory production environment
* Problem solving ability, experimental planning and adaptability
* Excellent scientific knowledge of PCR and ability to apply knowledge to problem solving manufacturing issues
* Project management skills
* Excellent interpersonal and communication skills
* Experience in process analysis and improvement strategies
* Knowledge of QMS, quality procedures and compliance to regulatory standards such as CE IVD.
* Knowledge of QC procedures and history of identifying appropriate criteria for performance measurement
* Ability to provide leadership to members of the technical team and drive urgency
* Willingness to learn and challenge existing ideas and practices

If you think you match the skills listed above and are looking for a new challenge in the Biotech industry, then please apply with your CV or call Thomas Nash on (0) for a completely confidential chat about your situation.