Manufacturing Senior Scientist

**Manufacturing Senior Scientist**

**Opportunity**

This 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**:
**Equal Opportunities**:
FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.