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Biotechnology Research Scientist
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**Job Summary**
The post holder will be a highly motivated and organized individual with expertise in gene and cell therapy, process development, and biotechnology. The successful candidate will be expected to lead a team within the function and contribute to the development of processes suitable for cGMP manufacture of high-quality therapeutic products.
**Key Responsibilities**
- Contribute to the design and development of viral vector manufacturing projects, collaborating with cross-functional teams to achieve project goals.
- Act as a subject matter expert for one or more aspects of the viral vector process, providing technical guidance and support to colleagues.
- Co-author the CMC section of regulatory submissions, including INDs and BLAs, to support regulatory filings.
- Participate in the evaluation of novel technologies and automation for introduction into GMP clinical production, ensuring seamless integration and process optimization.
- Develop and implement processes for the manufacturing of viral vectors, including design and execution of experiments to characterize and optimize critical process parameters.
- Perform Design of Experiments (DoE) and statistically analyze data for viral vectors purification, ensuring compliance with regulatory requirements.
- Design and execute experiments leading to the development and implementation of Product and Process improvements, driving process efficiency and quality.
- Author development and technology transfer reports, SOPs, and contribute to and review BMRs and regulatory documentation, ensuring accuracy and compliance.
- Lead the technology transfer to the Manufacturing group, ensuring smooth transition and process implementation.
- Participate in meetings and lead discussions, sharing results clearly and logically, and support instrument maintenance and calibration, and general lab housekeeping.
- Work independently with external service providers, ensuring effective collaboration and communication.
- Perform other duties as required, following consultation with the post holder, and adhere to all health and safety guidance provided by the Company.
