CMC Program Manager (Europe) - London


London, England, United Kingdom

CMC Project Management

Location: London, UK

Reporting to: VP, CMC Program Management (Menlo Park)

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 individual to join a London-based team responsible for planning, budgeting, integrating, tracking and communicating CMC activities for the Company’s product development programs. This will include working with internal stakeholders, academic collaborators, strategic partners and the Company’s designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) in Europe.

Responsibilities

  • Execute best project management practices for CMC activities
  • Establish, document, track and communicate CMC timelines, objectives, deliverables and budgets
  • Facilitate problem-solving, contingency planning, and decision-making
  • Ensure linkage between strategy and operational activities
  • Co-ordinate cross-functional communication and integration
  • Other activities as may be assigned

Requirements

Candidate must possess:

  • Experience in the biotechnology or pharma industry with a primary focus on project/program management of CMC related activities
  • Solid understanding of biological product development phases
  • Ability to travel to EU CMO and CTO sites, and as required US or other international sites

Education & skills

  • A minimum BSc or equivalent in Biological Sciences, Bioengineering, Chemistry or an associated discipline
  • A PMP or equivalent certification
  • Experience of managing CMO/CTO relationships and projects
  • Working 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
  • Travel to EU CMO and CTO sites is required. Some travel to US or other international sites may be required
  • Fluency in French, German or Italian a plus