Gmp Translation Officer

3 weeks ago


Edinburgh, United Kingdom RoslinCT Full time

**GMP Translation Officer**

**Location**: Charles Darwin House, Technopole, Edinburgh

**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 dream role**
- An exciting opportunity for a **GMP Translation Officer **to join our Development team
- Support technology transfer and GMP translation activities for the delivery of new cell and gene therapies into the GMP manufacturing facility
- Support evaluation and adoption of new cell and gene therapy manufacturing technologies
- Implement new processes and products, including process descriptions, from our clients into the RoslinCT Development team and RoslinCT Manufacturing
- Partner closely with MSAT, Production, QA, and Supply Chain teams to ensure the seamless transfer of processes between departments
- Develop new technical protocols, SOPs and related technical documentation for technology transfer and development of manufacturing processes
- Provide cross-functional technical support and collaborative work with the MSAT, Production, QA and Supply Chain teams
- Aid with the provision of training to Manufacturing staff on any new Manufacturing processes transferred into cell and gene therapy Manufacturing
- Support in technical investigations and generation and approval of technical reports to support troubleshooting of issues
- If required, perform routine tissue culture activities and/or processes and/or quality control testing for a range of pluripotent, progenitor and immune system cells
- Day to day housekeeping and administration of the dedicated Development facilities to ensure a high standard of organisation at all times with shared responsibility for out-of-hours cell culture maintenance.

**About you**
- Experience in mammalian cell culture (including feeding, passaging, cryopreservation, thawing) particularly within stem cells (i.e. hematopoietic, pluripotent, mesenchymal)
- Experience in executing GMP Manufacturing processes for cell and/or gene therapy
- Experience in working with cGMP systems and UK/EU/FDA regulations for medicinal products
- Experience writing technical documentation such as validation and technology transfer protocols, batch records, and SOPs
- A good standard of written English and the ability to write accurately and clearly
- Excellent communication and interpersonal skills, with the ability to build strong working relationships internally and externally
- Competent in the use of Microsoft Office products
- Exceptional organisational and planning skills with the ability to multi-task in a fast-paced environment
- You will be able to create a positive environment through self-awareness and social skills
- Excellent attention to detail with a real desire to continually develop and improve our processes.

**Qualifications**
- A MSc in a Bioprocess Engineering, Biotechnology or Life Sciences with at least 2 years' relevant industry experience, or equivalent relevant industrial experience

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