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.
• Providing specialist training to manufacturing staff supporting the introduction of new manufacturing processes, changes, and improvements.
• Supporting (as SME) technical investigations and out of specifications generating, reviewing, and approving technical reports to support timely close-out of QMS.
• Supporting the troubleshooting of process excursions/out of trends as required.

About you

• A minimum 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 processes.
• 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 solutions to complex problems.
• Contributes to identifying and completing continuous improvement activities to reduce costs, increase yield, and productivity for the area.
• Good organizational 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.

Next Steps

If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.

At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.