Looking for a highly motivated and organized individual with expertise in gene and cell therapy, process development, and biotechnology. The ideal candidate will lead a team within this function, demonstrating proven technical skills in viral vector or vaccine upstream production systems, including multi-layer culture systems and bioreactor platforms, preferably with adherent cell culture. Additionally, proficiency in associated analytical methods such as Cell-Based Assays, Flow Cytometry, and ELISA is required. This role necessitates close collaboration with other departments and team members to contribute to the development of processes suitable for cGMP manufacture of high-quality therapeutic products.
Key Responsibilities;
Contribute to the strategy design and development for viral vector manufacturing projects.
Collaborate with different departments within the company to obtain and/or provide detailed viral vector process development project strategy.
Act as the subject matter expert for one or more aspects of the viral vector process in cross functional projects.
Co-author the CMC section of regulatory submissions that support regulatory filings including INDs and BLAs.
Participate in evaluation of novel technologies and automation for introduction into GMP clinical production.
Develop processes suitable for the manufacturing of viral vectors.
Design and perform experiments to characterize and optimize critical process parameters.
Perform Design of Experiments (DoE) and statistically analyse data for viral vectors purification.
Design and execute experiments leading to the development and implementation of Product and Process improvements.
Author development and technology transfer reports, SOPs, contribute and review BMRs, and regulatory documentation.
Leading the technology transfer to Manufacturing group.
Participate in meetings and leading discussions sharing results clearly and logically when required.
Support instrument maintenance and calibration and general lab housekeeping.
Work independently with external service providers.
Any other duties as required following consultation with the post holder.
The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company.
Qualifications/Experience:
BSc (E), MSc (P) or PhD (P) in Biology/Biochemistry/Virology/Molecular Biology/Biotechnology or related discipline with relevant industry or academic experience
Familiar with a range of virus manufacturing.
Production of relevant biological products in small scale models (proteins, viral vectors, etc).
Experience of managing and leading a substantial team within a function
Process scale-up/ scale-out, and validation of manufacturing processes and controls.
Manages and leads a downstream group and co-ordinates the activities of the team.