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Senior / Project Scientist - Camden, Greater London, United Kingdom - Northreach
Description
Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector.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.
The Process Development Scientist will manage and oversee the day-to-day operations of process development (PD) activities for Advanced Therapy Medicinal Products (ATMPs) in the London areaProcess Development Management:
Manage and oversee daily PD activities in the London lab,
Support GMP activities where required to facilitate the development and improvement of ATMPs.
Collaboration:
Work closely with the Lead of Process Development to expand PD capabilities within budget constraints.
Project Development:
Lead the development of new PD projects, focusing on the commercialization of PSC RPE and the tech transfer of new ATMPs to GMP manufacturing.
Develop and maintain operating procedures and PD activity records to ensure accurate documentation for regulatory submissions for clinical trial approvals.
Continue the development process as new ATMPs advance from early to later-phase clinical trials, ensuring PD activities are aligned and translatable to a GMP environment for clinical manufacturing.
Cross-functionalCollaboration:
Collaborate with the Lead of GMP Manufacturing/QA and Lead of Analytical Development to ensure seamless integration and alignment of PD activities with GMP standards.
Organizational Skills:
Strong planning and organizational skills to meet ambitious targets.
Computer Skills:
Proficiency with common software packages (Windows, MS Office).
Cell Sorting Methods:
Experience with cell sorting techniques.
Cell Therapy Development:
Experience in cell therapy drug substance/drug product development.
Knowledge of the ophthalmic field.
GMP Experience:
At least 2 years of experience working within a GMP environment, familiar with local QMS systems and compliant with EU GMP/EMA/ICH standards.
Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age.
We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI.
