MSAT Scientist - Clinical Manufacturing

MSAT Scientist - Clinical Manufacturing

RoslinCT

Edinburgh, United Kingdom

Your new role

An exciting opportunity for a MSAT Scientist to join our team. You will be responsible for providing technical support to a range of cell therapy manufacturing processes including process technology transfers, process improvements, process trouble shooting and quality investigations/out of specification investigations. The role will focus on the technology transfer and clinical development of new cell therapy processes.

An element of the role includes the need to be present in the manufacturing clean room alongside Manufacturing colleagues.

Duties involved but not limited to are:

• Supporting Clinical Manufacturing on peak demand days with specific roles including CNC Support, Grade C Support, Scribe and Assistant Operator.
• Supporting commercial life cycle management changes via direct training, guidance and mentoring.

Further responsibilities include:

• Participating in client discussions.
• Writing process change controls, validation protocols, risk assessments, batch records and other relevant documentation for both ongoing and new manufacturing processes.
• Provide specialist training to manufacturing staff supporting the introduction of new manufacturing processes, changes, and improvements.
• Support (as SME) technical investigations and out of specifications generating, reviewing, and approving technical reports to support timely close-out of QMS.
• Support the troubleshooting of process excursions/out of trends as required.

About you

• A minimal of 3 years’ experience within GMP manufacturing and/or process technology transfer roles preferably in the Cell and Therapy industry.
• Hands-on cGMP experience with cell culture and various process manufacturing activities. Experience in working with iPSCs, MSCs or hESC lines is preferable.
• Experience in working with different cell culture platforms including closed system manufacturing process.
• Experience working to EU, MHRA and FDA regulations.
• Experience in writing technical documents such as process change controls, validation protocols, batch records and standard operating procedures.
• Excellent attention to detail, proven problem solver, self-motivated and positive with a desire to develop technically in their area of expertise.
• Can do attitude with a determination to succeed and provide solution to complex problems.
• Contributes to identifying and completing continuous improvement activities to reduce costs, increase yield and productivity for the area.
• Good organisational and planning skills with the ability to plan whilst delivering results to deadline.
• Excellent oral and written communication skills; able to explain technical or complex. concepts in a clear format to both technical and non-technical audiences.
• Proven ability to learn and share knowledge with the rest of the manufacturing team and enable them to successfully perform new manufacturing processes.

Qualifications

• A degree in a Life Science discipline or relevant equivalent experience.