Report this ad

Location: London, UK
Reporting to: Associate Director
Job summary
We are looking for a viral vector scientist to join the Cell and Gene Therapy Technology Department to support GMP manufacture and commercialization of gene therapy products at CDMOs. This role requires someone with good knowledge of viral vector processing or GMP manufacture, with an interest in process validation and data analysis. You will work with cross functional teams and with CDMOs to generate appropriate documentation to monitor batch process performance.
Key Elements and Responsibilities
Support clinical and commercial vector production at CDMOs
Review executed batch records, change controls, deviations, investigations
Participate in manufacturing investigations in collaboration with other departments
Collect, assemble, analyse and summarise production data
Support activities related to process characterization and validation/qualification including data analysis using appropriate statistical methods
Support development and optimization of vector production at CDMO
Work with QA, QC, Reg, CMC project management and other departments to advance programs
Support implementation of process changes
Author/ review of technical documents related to Health Authority submissions, Process Performance Qualification deliverables and process monitoring

Requirements
Required knowledge
Relevant experience in the biotechnology industry which could include cell culture, purification or fill finish (industrial placement experience can be counted)
Experience in GMP manufacture of vectors or biologics for pre-IND to phase III programs is advantageous
Experience in Manufacturing Operations or Process Development,

Skills & Abilities
Understanding of quality systems
Ability to work in a fast-paced environment
Good organizational skills and time management to deliver results
Good verbal and written communication skills
Flexibility and adaptability for re-prioritizing tasks
Ability to learn and apply new concepts
BSc or MSc in Biology, Biochemical Engineering, or related field
Good understanding of Vector or Biologics manufacture
Ability to evaluate and interpret characterisation and manufacturing data
Knowledge of statistical data analysis
Attention to detail
Working across cross functional teams to drive results
Ability to visualize / present data in order to communicate ideas, concepts and results to technical and non-technical audiences
Interest in continuous improvement of processes

Education
BSc or MSc in Biology, Biochemical Engineering, or related field
Good understanding of Vector or Biologics manufacture