Technical Transfer Scientist

Job Description

The CompanyBBI Solutions has served the global diagnostics industry for over 50 years, as a leading developer and manufacturer of raw materials and finished test platforms for the in-vitro diagnostics market. Product ranges include antigens, antibodies, enzymes, serumsand plasmas as well as renowned labels for lateral flow and ELISA assays.Our mission is to deliver exceptional products and technologies that people rely on to enjoy a better quality of life. Through innovation, partnership, effective delivery and the collaboration of our people, we constantly strive to help set industry standards,engender trust and build our reputation for excellence.We currently have an exciting opportunity for a Technical Transfer Scientist to join us on a permanent basis at our Crumlin site.BenefitsThe salary offered for this role is competitive and makes up part of BBIs attractive benefits package, which includes:

• 5% contributory pension scheme
• Life Assurance
• Private health care scheme
• Generous annual leave package totalling 32 days (inclusive of bank holidays)
• Cycle to work scheme

The RoleAs a Technical Transfer Scientist, you will be involved in the transfer and validation of new products at BBI Crumlin. The role will require working cross-functionally to support the transition of new products from design concept through to routine productionand will involve implementing standardised work instructions and processes to provide a consistent approach to technical transfers throughout BBI Crumlin. The role will also support continuous improvement activities at BBI Crumlin.Key responsibilities will include but not be limited to;

• Supporting R&D in the design and development of suitable manufacturing and/ or QC processes for transfer to Operations teams
• Generating process documentation, including process FMEAs, Bills of Materials, transfer to production plans, pilot batch protocols and reports.
• Assisting the co-ordination of pilot batch activities and ensuring appropriate training plans are in place.
• Supporting Capex and defining tool specifications
• Executing validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives. Support the preparation of Validation Master Plans, Summary Reports and other required documentation for a validationexercise.
• Ensuring project work is carried out in compliance with regulatory and company requirements. Providing validation support and advice to other areas of the business as required.
• Ensuring good communication with the team and other departments and Sites as appropriate.
• Meet agreed targets for project completion as defined by each project plan
• To conduct and support BBIs Continuous Improvement initiatives, activities and events
• Implement appropriate Lean Six Sigma Tools
• Through appropriate Lean Six Sigma methodologies manage appropriate projects in line with the companys Goal Tree / Objectives.
• Implement appropriate training of Lean Six Sigma skills as part of the overall strategy.
• Facilitate appropriate Kaizen evets, workshops, Just Do It (JDI) to enable rapid change
• Support Continuous Improvement Project selection, Kaizen events, reporting and tracking as directed by Technical Director or Operational Excellence Leader
• Lead certain Projects as directed by Global Operations Leadership, Director of Technical Operations or Operational Excellence Leader. with appropriate supervisor
• Support the Operational Excellence Team in appropriate Continuous Improvement KPIs, Metrics.
• Perform other related duties and projects as assigned or required, to identify business improvement projects, using a Lean methodology and Lean tools.

RequirementsThis role would be ideally suited to a person trained in design control and risk management who has experience of ISO13485 and manufacture of medical devices. Six Sigma Green Belt certification would also be advantageous.If you are an internal employee applying for this vacancy you and your manager are required to complete an internal transfer form. This needs to be completed in full and attached to your application along with your CV and cover letter.