Associate Scientist, Vector Operations MSAT

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