GMP Production Scientist

Full Job Description

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