Principal Scientist, Viral Vector

Location
London, United Kingdom
Posted
Jul 14, 2021
Ref
BFA305252B
Required Education
Bachelors Degree
Position Type
Full time
Location: London, UK

Reporting to: Director, Vector Manufacturing Science and Technology (MSAT)

The Principal Scientist in the Viral Vector MSAT team will contribute to activities related to the development and cGMP production of lentiviral vectors at contract and development manufacturing organizations (CDMOs) and at Orchard's process development laboratory. Such activities will include technology transfer, scale-up, execution and validation of manufacturing processes and controls as well as supporting regulatory filings, to support Orchard's innovative cell and gene therapy product programs from Phase I clinical trials through to commercial, licensed products. The Vector MSAT team is part of the wider technical Cell and Gene Therapy Technology team, which includes process development, analytical and cell process scientists.

Responsibilities
  • Workstream lead representing vector / plasmid functions at technical, CMC project and planning meetings
  • Orchard lead for process development activities at CDMOs including designing and planning studies and subsequent data analysis.
  • Lead Quality by Design implementation for Vector workstream and definition of process control strategy depending on program stage
  • Collaborate with CDMOs to coordinate and manage GMP manufacture, testing and fill finish of lentiviral vectors
  • Provide expert review and approval of master production records for manufacture of lentiviral vector batches
  • Provide on-site person-in-plant oversight during production campaigns and key development/validation activities
  • Provide expert review and analysis of executed batch and test records to assess performance of GMP batches
  • Assist with the reporting, investigation and resolution of deviations encountered during GMP production activities
  • Provide expert support for plasmid manufacture and their use in lentiviral vector GMP production
  • Liaise with other functions within the Cell and Gene Therapy Technology team as appropriate
  • Help to co-ordinate production activities within the QA, QC, pre-clinical and clinical development, commercial and project management departments to ensure the successful achievement of company timelines and milestones
  • Ensure the ongoing security of the supply chain for raw materials and intermediates to assure the uninterrupted performance of lentiviral production operations and provision of material for pre-clinical, clinical and commercial programs
  • Author, review and approve development/validation protocols and reports
  • Provide expert support for data collation, authoring and data integrity of regulatory documentation.
  • Other activities as may be assigned

  • Requirements

    Job Requirements

    Job Requirements

    The ideal candidate for this position will have in-depth experience of process development and / or large-scale cGMP production of viral vectors, especially lentiviral vectors, including, upstream cell culture, downstream processing, and fill finish operations. Experience of plasmid production is advantageous.

    Candidate must possess:
  • MSc / Ph.D in bioprocessing, chemical engineering, vector biology, or biological sciences
  • Ability to work independently or with minimal oversight
  • Proven track record of working in development, validation and production operations
  • Ability to analyse data using appropriate statistical methods
  • Experience with:

  • o Mammalian cell and microbial cell culture systems

    o Adherent and suspension cell culture systems, stable cell lines and transient transfection

    o Harvest and downstream purification operations including clarification filtration, chromatography and tangential flow filtration

    o Aseptic processing and fill finish

    o Vector analytical methods

    o Plasmids, cell banks and testing requirements

    o Validation of manufacturing processes and controls
  • Knowledge of FDA, EMA, GMP and ICH regulatory requirements
  • Knowledge of Quality Systems and QBD as they relate to GMP production operations, process optimization and process validation


  • Other Requirements

    • Organizational skills• Excellent written and oral communication skills• Ability to operate in a fast-paced, multi-disciplinary industrial environment• Ability to work independently, lead and co-ordinate technical aspects of activities across multi-functional teams• Experience of facility, and production equipment design and validation, including IQ, OQ & PQ preferred• Personnel and project management skills• There is a potential for this position to require on site person-in-plant presence at CDMOs. Therefore, ability to travel is a pre-requisite