Manufacturing Senior Scientist

Job Description

Manufacturing Senior ScientistAn amazing opportunity for an experienced Senior Scientist to join the Manufacturing team at an innovative and vibrant biotechnology company. This company combines amazing work with an amazing culture - where you will be designing and delivering cuttingedge and outstanding new healthcare solutions to market with an unbeatable team. The role represents the prefect opportunity for an immunoassay specialist to make extensive use of their skills working on a variety of exciting projects, while building a careerwith a company that values and fosters their talent. If this role sounds like it could be the perfect fit for you, or you would like to know more, then get in touch! We would love to hear from you. An excellent salary and benefits package are on offer to thesuccessful candidate, in addition to other amazing perks and bonuses.OpportunityThis role is full-time/permanent and will be based in either Stirling or Motherwell depending on your preference. The role will be working days Monday to Friday (08:30 to 17:30) but if your preference is to work 24/7 shifts (4 on 4 off) then we would stilllove to hear from you as there could be an opportunity to work in our shift team if this was your preferred choice.Key Responsibilities:

• Lead multiple significant technically complex projects and be responsible for their delivery within set timelines.
• Lead the development of key reagent activities to optimise performance and yields of new projects to meet commercial demand.
• Lead continuous improvement projects for existing product lines and provide technical input to performance and yield investigations and assist in reaching solutions.
• Lead the scale up of reagent processes and complete validation and training activities to facilitate commercial manufacture.
• Lead the design, development and qualification of in process tests to track and trend performance of assay reagents and establish relationships with final product performance.
• Gain technical understanding of the future products that are under research and development in readiness for transfer into manufacturing.
• Create, develop and undertake new experiments in this specialist field, use statistical methods to analyse results and make the appropriate scientific conclusions to define next steps required.
• Prepare and present project results and developments for senior management and additional departments across the business.
• Challenge scientific and technical rigour of experiments and experimental design, and challenge approach to running of protocols and experiments.
• Keep up to date with developments in reagents and chemistry that affect our products, through literature and external links.
• Understand business goals and set and agree appropriate technical goals within team.
• Provide day-to-day direction for experiments and project plans of team in line with overall business goals and budget.
• Adhere to all relevant regulatory GLP, GMP and GDP requirements and set example to others.
• Ensure Design Control and Validation procedures are adhered to for all experiments and that reports and procedures are written and approved that meet Quality and Regulatory criteria set.
• Follow and comply with all relevant internal quality and H&S processes and procedures and ensure compliance within the reagent manufacturing department.
• Raise and monitor Change projects and Non-conformances, lead investigations and corrective actions and see through to closure.
• Technically review completed documentation and reports for accuracy, providing feedback to team members to support a Right First-Time culture.

About You:We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem solving, along with the following experience:Essential Experience:

• Minimum of Degree level qualified in Chemistry or Biochemistry.
• Extensive experience of working within a regulated laboratory environment.
• Experience in protein chemistry processes such as protein to protein coupling and protein to surface coupling.
• Experience and understanding of characterisation techniques used to assess performance of manufactured materials such as Flow Cytometry, HPLC and Dynamic Light Scattering.
• Experience of equipment-based manufacture at varying scales using techniques such as FPLC, TFF/Hollow fibre filtration etc.
• Knowledge of diagnostic immunoassay technology.
• Experience or good knowledge of the ISO13485/Medical Device standard.
• Experience of managing projects and scientific teams to meet set company timelines.
• Ability to write clear and concise protocols and process instructions for complex reagent manufacturing processes and delivering appropriate level of training to operators.
• Computer literacy, data analysis interpretation skills and good attention to detail.
• Experience in Statistical analysis and Design of Experiments.
• High level of problem-solving skills and innovation.
• Experienced in summarising and communicating project data for senior staff and stakeholders.
• Knowledge and experience of validation requirements to ensure projects suitable for commercial use.

Next Steps:Apply online in the first instance, or contact Liam Baxter at Tel: or email your CV toEqual Opportunities:FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process