Process Development Scientist

Summary of the role

A Process Development Scientist is at the heart of turning a lab-based discovery into a viable, scalable, and safe product. They are the inventors and problem-solvers who bridge the gap between research and commercial manufacturing.

A Process Development Scientist is an expert who designs, develops, and optimises manufacturing processes for new products or improves existing ones. Their main objective is to create a process that is robust, efficient, cost-effective, and compliant with regulatory standards. They ensure that a product can be consistently and reliably manufactured at a larger scale than a research lab can handle, without compromising its quality or efficacy.

The title for this role can vary between companies and fields; similar job titles include:

• Associate Scientist, Process Development
• Process Development Engineer
• Bioprocess Scientist/Engineer
• Manufacturing Scientist
• Technical Operations Scientist/Specialist
• Senior Scientist/Engineer, Process Development
• CMC Scientist

Typical Duties

The duties of a Process Development Scientist are a mix of hands-on experimentation, data analysis, and strategic planning:

• Process Optimisation and Development: Your primary duty is to develop and refine manufacturing processes. This involves designing and executing experiments to find the best conditions for a process (e.g., cell culture conditions, purification steps) to maximise yield, purity, and safety.
• Scale-Up and Technology Transfer: You will be responsible for scaling up a process from a small lab-scale to a larger manufacturing scale. This involves performing pilot trials and ensuring a smooth transition of the process to the manufacturing team.
• Troubleshooting and Investigation: When issues arise during production, you’ll be a key investigator. You’ll analyse data to find the root cause of the problem and design experiments to test and implement solutions.
• Documentation and Regulatory Support: You will be responsible for generating detailed technical reports, protocols, and Standard Operating Procedures (SOPs). This documentation is critical for regulatory submissions and to ensure the process is repeatable and compliant.
• Cross-functional Collaboration: You’ll work closely with a variety of teams, including Research & Development (R&D), Manufacturing, Quality Assurance (QA), and Regulatory Affairs. Your role is to communicate findings and ensure the process meets the needs of all stakeholders.

The core responsibilities are similar for advanced therapies and life sciences, but the specific technical focus is different:

Advanced Therapies: Your work would be focused on optimising processes for cell and gene therapies. This involves a deep understanding of cell culture, viral vector production, and specialised equipment like bioreactors for cell expansion. The challenge is often to work with personalised, highly sensitive biological materials.

Wider Life Sciences: You might be working on a broader range of products, such as monoclonal antibodies, vaccines, or traditional small-molecule drugs. The processes would involve large-scale fermentation, protein purification techniques (like chromatography), and a focus on industrial bioprocessing.

Key Skills and Qualifications (UK)

Essential Qualifications: A Bachelor’s or Master’s degree in a relevant scientific or engineering discipline is a must. Common degrees include Chemical Engineering, Biotechnology, Biochemistry, and Molecular Biology. A PhD is highly desirable, especially for more senior roles, and can often accelerate career progression.

Essential Skills:

• Technical Expertise: A deep understanding of the scientific principles behind the manufacturing process you are working on.
• Analytical and Problem-Solving: The ability to use data to understand complex processes, identify problems, and design logical solutions.
• Communication: Excellent written communication skills are essential for creating clear documentation and reports. Verbal skills are key for presenting findings to various teams.
• Teamwork: The ability to collaborate effectively with scientists, engineers, and technicians from different disciplines.

Desirable Certifications: A solid understanding of Good Manufacturing Practice (GMP) is essential. Any training or experience with quality systems, Lean Manufacturing, or Six Sigma methodologies is a significant advantage.

Salary Expectations (UK)

Starting Salary: For a new graduate with a relevant degree, a starting salary for a Process Development Scientist is typically in the range of £30,000 – £40,000 per year. A PhD graduate would likely start at the higher end of this range or even higher.

After 3-4 Years: With a few years of experience, a strong track record of successful projects, and the ability to work independently, a scientist can expect to earn between £45,000 – £60,000 or more. Progression to Senior Scientist or Principal Scientist roles will see salaries rise significantly.