Scientist Senior Scientist Product Development
6 days ago
Job Overview:
We are seeking a highly skilled Scientist / Senior Scientist to join our team at Northreach, a dynamic recruitment agency specializing in the Advanced Therapies sector. As a key member of our team, you will play a crucial role in managing and overseeing process development activities for Advanced Therapy Medicinal Products (ATMPs) in the London area.
Key Responsibilities:
- Process Development Management: Lead and manage daily process development activities in the London lab, ensuring seamless execution and timely delivery.
- GMP Support: Provide support for GMP activities as required, facilitating the development and improvement of ATMPs.
- Collaboration: Work closely with the Lead of Process Development to expand PD capabilities within budget constraints, driving innovation and growth.
- 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.
- Documentation: Develop and maintain operating procedures and PD activity records to ensure accurate documentation for regulatory submissions for clinical trial approvals.
- Clinical Trial Support: 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-functional Collaboration: 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: Demonstrate strong planning and organizational skills to meet ambitious targets, ensuring timely delivery and high-quality results.
- Computer Skills: Proficiency with common software packages (Windows, MS Office) is essential for this role.
Desirable:
- Cell Sorting Methods: Experience with cell sorting techniques is highly desirable.
- Cell Therapy Development: Experience in cell therapy drug substance/drug product development is highly valued.
- Ophthalmic Knowledge: Knowledge of the ophthalmic field is highly desirable.
- 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, is highly desirable.
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 businesses that promote DEI.
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