MSAT Scientist

Summary of the role

A Manufacturing Science and Technology (MSAT) Scientist ensures that a product can be consistently and reliably manufactured, bridging the gap between research and commercial manufacturing. You’ll be at the forefront of bringing innovative cell and gene therapies and other biopharmaceutical products from the lab to patients.

An MSAT Scientist is a technical expert responsible for the lifecycle management of a manufacturing process. This means they are involved from the moment a process is transferred from process development to manufacturing, and they continue to support it throughout its entire life. Their main goal is to ensure the process remains in a state of control, is continuously improved, and is fully compliant with all regulations. They act as the technical point of contact for the manufacturing floor, solving complex problems and driving innovation.

Typical duties

The duties of an MSAT Scientist are a mix of technical investigation, process improvement, and cross-functional collaboration:

• Technology Transfer and Process Scale-Up: You will be responsible for a smooth and successful transfer of a manufacturing process from a smaller scale (e.g. in a development lab) to the large-scale manufacturing environment. This involves troubleshooting any issues that arise during the scale-up and ensuring the process is robust.
• Process Monitoring and Continued Process Verification (CPV): You will analyse manufacturing data to monitor process performance, identify trends, and ensure the process is in a state of control. You’ll use this data to identify opportunities for improvement and to support regulatory filings.
• Deviation and Investigation Management: When a process deviation or a quality event occurs on the manufacturing floor, you are the technical lead for the investigation. You’ll apply your scientific and engineering knowledge to find the root cause and develop corrective and preventive actions (CAPAs).
• Process Improvement and Optimisation: You will constantly look for ways to make the manufacturing process better. This could involve implementing new technologies, optimising existing steps to improve yield or efficiency, or reducing costs.
• Documentation and Regulatory Support: You will write and review critical technical documents, such as protocols, reports, and regulatory filings. You’ll also be a key contact for regulatory bodies like the MHRA during audits and inspections.

The core responsibilities are similar for both advanced therapies and wider life sciences, but the context and focus of the work change:

Advanced Therapies: The work would be highly focused on the unique challenges of cell and gene therapies, such as the short shelf life, personalised nature, and complex supply chain. You would be deeply involved in processes like viral vector production and cell culture.

Wider Life Sciences: You might be working on a broader range of products, such as monoclonal antibodies or vaccines. The engineering challenges might be more focused on large-scale fermentation and protein purification techniques.

Key Skills and Qualifications (UK)

Essential Qualifications: A Bachelor’s or Master’s degree in a relevant scientific or engineering discipline (e.g., Biochemical Engineering, Biotechnology, Chemistry) is almost always required. A PhD is highly desirable, especially for more senior roles, as it demonstrates a deep scientific and analytical capability.

Essential Certifications: A deep and practical understanding of Good Manufacturing Practice (GMP) is crucial. You’ll need follow GMP and apply its principles to solve complex manufacturing problems. Experience with statistical software and data analysis is also highly valued.

Essential Skills:

• Problem-Solving and Analytical Skills: The ability to logically analyse data, identify trends, and find the root cause of a problem is paramount.
• Technical Expertise: A strong understanding of the manufacturing process you are supporting is a must.
• Communication: Excellent verbal and written communication skills are necessary for writing technical reports and effectively collaborating with diverse teams.
• Project Management: The ability to manage multiple projects and timelines, often under pressure.

Salary Expectations (UK)

Starting Salary: For an entry-level MSAT Scientist in the UK, a starting salary is typically in the range of £35,000 – £45,000 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 and a strong track record of successful projects, an MSAT Scientist can expect to earn between £45,000 – £60,000 or more. Progression to Senior MSAT Scientist or management roles can lead to even higher salaries.