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Senior / Principal Scientist - Process Development
3 months ago
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.
Apply now, read the job details by scrolling down Double check you have the necessary skills before sending an application.Job Overview :
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 area. Additionally, the role involves supporting good manufacturing practice (GMP) activities as needed, to enhance both existing and new ATMPs and contribute to the continuous improvement of the pipeline.
Key Responsibilities:
- Process Development Management: Manage and oversee daily PD activities in the London lab,
- GMP Support: 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.
- 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.
Experience, Knowledge, and Skills:
Essential:
- Aseptic Processing and Cell Culture: Expertise in aseptic processing and substantial experience in cell culture, specifically embryonic stem cells (ESC) and induced pluripotent stem cells (iPSC) culture and differentiation.
- Manufacturing Experience: Background in biopharmaceutical or cell and/or gene therapy manufacturing processes.
- Independence and Support: Self-motivated with the ability to work independently while effectively supporting team members when necessary.
- Team Player: Ability to thrive as a team player in a fast-paced environment.
- Professionalism and Detail Orientation: Professional presence and meticulous attention to detail.
- Organizational Skills: Strong planning and organizational skills to meet ambitious targets.
- Technical Proficiency: Ability to execute documented procedures effectively.
- Computer Skills: Proficiency with common software packages (Windows, MS Office).
- Positive Attitude: Positive working attitude with the flexibility to work across different teams.
Desirable:
- Cell Sorting Methods: Experience with cell sorting techniques.
- Cell Therapy Development: Experience in cell therapy drug substance/drug product development.
- Ophthalmic Knowledge: 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.
- Specialized Cell Culture: Experience in the generation, culture, and/or GMP manufacturing of retinal pigmented epithelial cells, stem cells, and retinal photoreceptor cells.
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. We strive to create a welcoming and inclusive environment for all employees.
