Process Development Scientist
About Us
We are a dynamic and growing manufacturing business specialising in high-quality, regulated products. Operating under ISO 13485:2016, we are committed to excellence across every stage of our operation—from development through to manufacturing and distribution. With a strong customer focus and collaborative team culture, we are seeking an innovative and driven Process Development Scientist to support the development of robust, scalable manufacturing processes for new and existing products.
The Role
We are seeking an innovative and hands-on Process Development Scientist to lead the development, optimisation and scale-up of products and manufacturing processes from development through to commercial manufacture.
Working closely with Transfer, Manufacturing, Quality and Operations, you will apply scientific principles to design robust, scalable processes that consistently deliver high-quality products. From proof-of-concept through process optimisation, verification and technology transfer, you will play a key role in ensuring products can be manufactured efficiently while meeting regulatory and quality requirements.
This is an exciting opportunity for a scientist who enjoys experimental design, problem-solving and translating laboratory developments into commercially viable manufacturing processes within a regulated ISO 13485:2016 environment.
Key Responsibilities
Process Development
· Design, plan and execute experimental studies to develop, optimise and characterise manufacturing processes for new and existing products.
· Investigate critical process parameters (CPPs) and critical quality attributes (CQAs) to establish robust and reproducible manufacturing processes.
· Apply Design of Experiments (DoE) and statistical analysis, where appropriate, to understand process performance and support process optimisation.
· Develop scalable manufacturing processes from proof-of-concept through laboratory development, pilot-scale studies and commercial manufacture.
· Identify and resolve technical challenges through scientific investigation and data-driven decision making.
· Evaluate new materials, equipment and manufacturing technologies to improve process capability and product performance.
· Generate and interpret experimental data, producing clear technical reports and recommendations to support development decisions.
· Collaborate with cross-functional teams to ensure process development activities align with product requirements, manufacturing capability and quality expectations.
· Support continuous improvement initiatives by identifying opportunities to enhance process robustness, efficiency and product quality throughout the product lifecycle.
Technology Transfer
· Transfer optimised products and manufacturing processes into routine production.
· Develop and execute technology transfer plans to ensure successful implementation into manufacturing.
· Prepare and maintain process specifications, manufacturing instructions and technical documentation to support product introduction.
· Ensure critical process knowledge is effectively transferred to Manufacturing and Quality teams.
· Support process verification activities and early manufacturing batches, monitoring performance and implementing improvements where required.
· Collaborate closely with Manufacturing, Quality and Supply Chain to ensure smooth and efficient product introduction.
· Create and review Bills of Materials (BOMs) and associated manufacturing master data.
Validation & Technical Support
· Support the preparation, execution and review of validation protocols, including IQ, OQ and PQ activities where appropriate.
· Assist with commissioning and qualification of new or modified manufacturing equipment and processes.
· Provide scientific input into deviations, non-conformances, CAPAs and change controls.
· Perform process risk assessments using recognised risk management tools such as FMEA.
· Support ongoing process verification and continuous monitoring to ensure consistent manufacturing performance.
Documentation & Compliance
· Prepare and maintain development reports, technical documentation, validation documentation, risk assessments and process specifications.
· Develop and maintain Standard Operating Procedures (SOPs), manufacturing instructions and associated technical documentation.
· Ensure all activities comply with ISO 13485:2016, internal Quality Management System (QMS) requirements and applicable regulatory standards.
· Support internal, customer and quality audits through accurate and compliant documentation.
Cross-Functional Collaboration
· Work collaboratively with Transfer, Manufacturing, Quality and Operations throughout the product development lifecycle.
· Provide scientific and technical support to Manufacturing teams during process implementation and optimisation.
· Deliver technical training and facilitate effective knowledge transfer into routine manufacturing operations.
· Build strong working relationships across departments to ensure successful project delivery and continuous improvement.
Safety & Continuous Improvement
· Follow all company safety and regulatory requirements.
· Promote a culture of scientific excellence, innovation and continuous improvement.
· Identify opportunities to improve development methodologies, manufacturing processes and product quality through the application of sound scientific principles and data-driven decision-making.
What We're Looking For
· Degree in Chemistry, Biological Sciences, Biomedical Science, Biotechnology, Pharmaceutical Science, Chemical Engineering or a related scientific discipline.
· Experience in process development, product development or manufacturing science within a regulated environment.
· Experience designing, planning and executing experimental studies to optimise products or manufacturing processes.
· Strong understanding of scientific method, experimental design and data analysis.
· Experience in supporting process scale-up and technology transfer into manufacturing.
· Knowledge of process validation principles and risk management methodologies.
· Excellent technical writing, documentation and report-writing skills.
· Strong analytical and problem-solving abilities with a practical, hands-on approach.
· Excellent communication and interpersonal skills with the ability to work effectively across multidisciplinary teams.
· Highly organised with the ability to manage multiple development projects simultaneously.
Why Join Us?
· Be at the forefront of developing innovative, life-enhancing products for manufacture.
· Play a key role in designing and optimising manufacturing processes that deliver high-quality products.
· Work within a collaborative and supportive multidisciplinary team where your scientific expertise will make a real impact.
· Gain exposure to product development, manufacturing, validation and continuous improvement within a regulated environment.
· Join a growing organisation committed to innovation, quality and professional development.
Ready to take your tech transfer skills to the next level?
Apply now with your CV and a covering letter outlining why you’re the perfect fit for this role.
Pay: £30,000.00-£40,000.00 per year
Benefits:
- Company pension
- Free parking
- On-site parking
- Sick pay
Work Location: In person
