Senior Scientist, Viral Vector MSAT - 12month Fixed Term Contract

Location: London, UK

Reporting to: Associate Director, Vector Operations

The Senior Scientist, Vector Production will assist in the oversight of activities related to the development and cGMP production of lentiviral vectors at contract and development manufacturing organizations (CDMOs). Such activities will include the scale-up, validation and execution of manufacturing processes and controls to support Orchard Therapeutics innovative cell and gene therapy product programs from Phase I clinical trials through to commercial.

Responsibilities

• Collaborate with CDMOs to coordinate and manage GMP manufacture, testing and fill finish of lentiviral vectors
• Provide expert compilation, review, editing and approval of master production records, standard operating procedures, development/validation protocols and reports
• Provide expert review and approval of executed batch, records, test records and associated documentation for release of lentiviral vector lots
• 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
• Provide on-site person-in-plant oversight during production campaigns and key development/validation activities
• Provide expert support for data collation, authoring and data integrity of regulatory documentation.
• Help to co-ordinate production activities with the research, pre-clinical development, QA, QC, 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
• Other activities as may be assigned

Requirements

Job Requirements

The ideal candidate for this position will have in-depth experience of the large-scale cGMP production of viral vectors, especially lentiviral vectors, including upstream cell culture, downstream processing, and fill finish operations.

Candidate must possess:

• BSc or MSc in bioprocessing, chemical engineering, vector biology, or biological sciences
• Ability to work independently or with minimal oversight
• Strong experience in the biotechnology or pharma industry with a primary focus on upstream cell culture, transfection, downstream processing, and fill finish operations for viral vectors and/or biologics
• Proven track record of working in development, validation and production operations
• Experience with:
  • Mammalian cell and microbial cell culture systems
  • Different bioreactor production systems and scales, including disposable single-use bioreactor systems
  • 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

• Personnel and project management skills
• Organizational skills
• Excellent written and oral communication skills
• Ability to operate in a fast-paced, multi-disciplinary industrial environment
• Experience of facility, and production equipment design and validation, including IQ, OQ & PQ preferred
• 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

Benefits

RECRUITERS

All employment offers and CV's are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.