Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.
We are working with a clinical stage biotech company with focus on Therapy Medicinal Products (ATMPs) at the forefront of clinical medicine. They pioneer the development of regenerative medicines �for ocular conditions. We are looking for a Senior GP Production Scientist to join the rapidly growing London based CMC division.
Job Description
- Responsible for day-to-day operation and manufacture of the RPE ATMPs in a GMP facility
- Maintain batch records, equipment logs and other production records to comply with cGMP in collaboration with fellow team members.
- Maintain batch records, equipment logs and other production records to comply with cGMP in collaboration with fellow team members.
- Experience of working within a GMP environment with at least 3 years local QMS system and in compliance to EU GMP/EMA/ICH.
- Good knowledge of Quality Management System (QMS) and cGMP.
- Ability to work independently as well as in a team in a fast-paced environment.
- Knowledge of regulatory guidelines and ensure compliance to EU GMP/ICH/FDA/EMA and other requirements.
- Professional presence and strong attention to detail is required.
- Technical proficiency that enables effective execution of documented procedures.
- Demonstrated experience with common computer software packages (Windows, MS Office).
- Good communication and problem-solving abilities.
- Experience in audit participation.
- Experience in Technology transfer.