Vice President, CMC Technical Operations - London


Full-time

London, England, United Kingdom

Technical Operations

Reporting to: Chief Manufacturing Officer

This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Orchard Therapeutics, Ltd. (OTL) is looking for an experienced individual to provide on-site senior management representation for CMC Technical Operations at the company’s London, UK office. Reporting to the US-based Chief Manufacturing Officer, this individual will be responsible for matrix management of the rapidly growing London-based team handling Analytical Operations, Cell Therapy Operations, Program Management, Quality Control and Vector Operations at the Company’s strategic partners and designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) in Europe.

Responsibilities

  • Provide senior level representation for CMC Technical Operations in the London, UK office
  • In coordination with the US-based functional line heads, provide matrix management of London-based staff responsible for Analytical Operations, Cell Therapy Operations, Program Management, Quality Control and Vector Operations at European CMOs, CTLs and strategic partners
  • As required, deputize for the Chief Manufacturing Officer at internal and external planning, project team and joint steering committee meetings
  • Monitor and facilitate the review and communication of CMC timelines, objectives, deliverables and budgets
  • Facilitate problem-solving, contingency planning, and decision-making for the matrixed CMC Technical Operations team
  • Facilitate linkage between OTLs strategic and operational activities
  • Facilitate internal cross-functional communication and integration of European CMC Technical Operations with US Technical Operations, and OTL’s research, clinical, regulatory, QA, business development and commercial groups

8. Other activities as may be assigned

Education & Skills

Requirements

Job Requirements

The ideal candidate for this position will have demonstrated senior management level experience of integrated CMC Technical Operations in the biotech/pharma industry, preferably for cell and gene therapy products.

Candidate must possess:

  • Solid understanding of biological product development from pre-clinical through to commercial
  • Proven track record of matrix management for complex programs
  • Ability to travel to domestic and international sites
  • A minimum BSc or equivalent in Biological Sciences, Bioengineering, Chemistry or an associated discipline
  • Experience of managing CMO/CTO relationships and projects
  • Expert knowledge of US and European regulatory requirements
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Fluency in French, German or Italian a plus