Manufacturing Biotechnologist

**Manufacturing Biotechnologist - Clinical Projects**

**Location**: NINE, 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**
- We are recruiting for a **Manufacturing Biotechnologist **to join our team as part of our continued growth and success.
- This position will be within the Manufacturing team responsible for the manufacture of various cell and gene therapy cell banks and drug products predominantly in the clinical phases of drug product development.
- The Manufacturing Biotechnologist will be responsible for performing direct hands-on activities associated with the manufacture of these products, meeting all required quality and regulatory standards.
- You will work as part of a shift team, performing hands-on manufacture of cell banks and clinical phase drug product according to Good Manufacturing Practice within a highly controlled clean room environment designed to make sterile injectable final products.
- Actively contribute to the successful process technical transfer and GMP translation from laboratory to cleanroom.
- Complete quality related documentation including manufacturing batch records, forms, and logbooks to a high level of GDP following all relevant standard operating procedures and instructions.
- Assist with change controls, deviations, and risk assessments.
- Support daily housekeeping activities, including but not limited to cleaning, stock control, and ordering materials.
- Participate in the qualification, calibration, and maintenance of manufacturing equipment.
- Preparation of standard operating procedures.

**About you**
- You will have experience or an educational background in stem cells, cellular therapies, or cell banking.
- Demonstrate enthusiasm of developing next-generational therapies for patients.
- You will have an awareness/understanding of a GMP cleanroom production environment.
- It would be beneficial, but not essential, if you have the following:

- Experience of Technical Transfer of processes in a GMP environment.
- Cell culture experience - specifically mammalian/stem cells.
- Awareness of UK legislative and regulatory framework relating to cell therapy products and tissue donation.
- Technical document preparation - SOPs, protocols, and project reports.
- Experience with Batch Production record - drafting and executing.
- Excellent computer skills with experience in Microsoft packages.
- You will have excellent written and verbal communication skills.
- Excellent organisational skills with the ability to multi-task in a fast-paced and dynamic environment.

**Qualifications**

**Next Steps**
- 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._