RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies. It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep. RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.
Technology Transfer Specialist - Cell and Gene Therapy
Location: Edinburgh BioQuarter
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
* An exciting opportunity for a Technology Transfer Specialist to join our team.
* You will be responsible for providing technical support to a range of cell and gene therapy manufacturing processes including:
o Process technology transfers
o Process improvements
o Process trouble shooting
o Quality investigations/out of specification investigations.
o Provisions of on the floor technical mentoring and guidance to Manufacturing personnel within the cleanroom Manufacturing suite.
* You will work directly with an MSAT Principal Scientist to deliver assigned technical projects/tasks ensuring project timelines are met according to internal and/or customer expectations.
* Support the transfer of new cellular therapy/gene edited processes into RoslinCT’s GMP manufacturing facilities working closely with RoslinCT’s clients and/or RoslinCT’s internal Development team.
* You will be an integral part of cross functional project teams including Development Manufacturing, QC, QA, Supply Chain and Project Management.
* Participate in client discussions to support the on-boarding of new projects and technologies.
* Complete process and facility gap assessments for new processes and work collaboratively with the Project Manager to generate a robust process transfer plan.
* Agree and generate final process descriptions.
* Write process change controls, validation protocols, risk assessments, batch records and other relevant documentation for both ongoing and new manufacturing processes.
* Develop new technical protocols, SOPs, and related technical documentation to support technology transfer and ongoing development of manufacturing projects.
* Complete GMP material assessments and finalize bills of materials.
* Support evaluation and adoption of new cellular therapy manufacturing technologies.
* 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
* Experience within GMP manufacturing and/or process technology transfer roles preferably in the Cell and Gene therapy industry.
* Hands-on cGMP experience with cell culture and various process manufacturing activities. Experience in working with iPSCs or hESC lines is preferable.
* Experience in working with different cell culture platforms including closed system manufacturing process e.g., bioreactors, cell processors is preferable.
* 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.
* Creates a positive environment through self-awareness and social skills.
* Emotional resilience and an ability to work under pressure with good humour.
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.