Associate Principal Technology Transfer Specialist - Cell and Gene Therapy

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!

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

• We are looking for a Cell and Gene Therapy - Technology Transfer Specialist to join our team.
• You will be responsible for providing technical support to ongoing commercial manufacturing of a CRISPR/Cas-9 gene edited autologous product.
• This includes managing process changes, process improvements, continuous process monitoring, process troubleshooting, quality investigations, and real-time on-the-floor guidance to Manufacturing personnel within the Manufacturing site.
• Partner closely with clients, the RoslinCT Development team, Manufacturing, QC, QA, Project Management and Supply Chain Teams.
• Investigate OOS and OOT from Manufacturing and/or from the CPV reports.
• Maintain awareness of process drift and initiate corrective actions as appropriate.
• Liaise with RoslinCT’s client and manage process changes and improvements via RoslinCT’s change control process.
• Lead any changes to processes or documentation and support the product life cycle management.
• Ensure staff are appropriately informed of the changes and supported throughout the change cycle.
• Complete GMP material assessments and finalize the bill of materials (BOM).
• Provide SME input to deviation investigations and reports. Co-ordinate technical troubleshooting and root cause investigations of events as required.
• Continually review the manufacturing operations and documentation instilling a lean, compliant and right first-time philosophy/culture.
• Provision of cross-functional technical support to, and work in partnership with, the Development, QC, QA and Supply Chain teams.
• Support evaluation and adoption of new cell therapy manufacturing technologies.
• Provide specialist required training to manufacturing staff on any new manufacturing processes/process changes.
• Provide on the floor technical training associated with the process and its associated equipment. Encourage a holistic, continuous and knowledge-based approach.
• Provide on the floor technical support and trouble-shooting guidance as required.
• Deliver assigned technical projects/tasks, ensuring project time lines are met according to internal and/or customer needs
• Write process validation protocols, risk assessments, batch records and other relevant documentation for both ongoing and any new manufacturing processes.
• Troubleshoot process excursion/failures as required.
• As required provide technical and process guidance support to junior members of the team to help in developing them to progress. If required provide line management support.

About you

• Experience working with cGMP systems and FDA/EU regulations within cell and gene therapy manufacturing.
• Experience in working within commercial manufacturing site.
• Hands-on cGMP experience with cell culture including 2D and scale up.
• Experience in writing technical documentation such as process change controls, validation protocols, batch records and standard operating procedures.
• Good analytical thinking with ability to process complex manufacturing problems as required.
• Ability to formulate realistic, tangible solutions to complex problems and expectations aligned with multi-project deliverables.
• Ability to analyse operational and technical data and communicate solutions and paths forward to senior and executive management including client representatives.
• Implementation of communication and control mechanisms to assure timely intervention when required.
• Ability to learn and share knowledge with the rest of the manufacturing team and enable them to successfully perform new manufacturing process.
• Excellent communication and interpersonal skills, with the ability to build strong working relationships internally and externally.
• Effectively manage and influence stakeholders’ and customer expectations.

Qualifications

• A degree in a Life Science discipline with at least 5 years’ experience in GMP manufacturing preferably in a Cell and Gene therapy industry.

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.