Manufacturing Batch Reviewer I

Manufacturing Batch Reviewer I

Location: Edinburgh BioQuarter, Little France

Who are we?

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here!

Due to the nature and training requirements of this role, applicants must have the legal right to work in the UK with sufficient permission to meet the needs of the position. We are unable to provide visa sponsorship for this role under the Home Office restrictions.

Why join us?

• The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career

• A generous salary package – we reward our people at the level they deserve

• 31 days of annual leave, plus 4 public holidays which increases with tenure

• A competitive company pension scheme to help you save for the future

• Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind

• Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us

• Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your new role

• An exciting opportunity to join the Manufacturing Batch Review Team (MBRT) as a Manufacturing Batch Reviewer I.

• Review executed manufacturing batch documentation (batch records, in-process data and environmental monitoring data) to ensure GMP compliance and adherence to operational SOPs.

• Investigate and impact assess technical problems identified during reviews, collaborating with Manufacturing and Quality departments.

• Assure timely communication of quality events identified during document audit with relevant departments, including raising deviations.

• Generate environmental monitoring reports investigating any discrepancies.

• Input manufacturing batch data into an analytical software programme for continued process verification (CPV).

• Provide regular feedback on findings during document review to relevant departments as appropriate.

• Evaluate trends and work pro-actively and collaboratively on improvement initiatives to reduce data errors and deviations.

• Work to ensure timely closure of packs for batch disposition and shipment to patient by working collaboratively with relevant departments.

• Assist in training and coaching relevant personnel to develop their GMP recording, review and technical writing skills.

• Attend MBRT meetings to provide appropriate feedback in respect status and progression of manufacturing documentation.

• Input batch-related data into Manufacturing and QA batch review trackers where applicable.

• Support with daily MBRT housekeeping activities, including but not limited to filing, photocopying and transferring documents to other RoslinCT sites.

About you

• Background in stem cells, gene or cell therapies, or cell banking within a regulated environment.

• Working knowledge of cGMP principles particularly aseptic processing, documentation and record management with an excellent understanding of UK, EU and FDA regulations.

• Experienced in following SOPs and maintaining high compliance standards.

• Skilled in technical writing and addressing GMP audit findings.

• Highly organised with strong planning, administrative and record-keeping skills.

• Excellent communication and interpersonal skills, building effective relationships across teams.

• Strong attention to detail, with a real desire to continually develop and improve our processes.

Qualifications

• A BSc in a Life Science subject or other equivalent laboratory experience.

• Minimum 1 years’ experience in Sterile Manufacture- and/or Quality-related role.

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.

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.