Technology Transfer Specialist

**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:

- Process technology transfers
- Process improvements
- Process trouble shooting
- Quality investigations/out of specification investigations.
- 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 ab