Associate Director, External Development and Manufacturing - FM4


Full-time

London, England, United Kingdom

CMC

Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare disease through innovative gene therapies.

Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies include three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion-dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.

This role is responsible for the overall health of key specific Contract Development and Manufacturing Organisations (CDMO) relationships with the OTL Technical Operations teams. The post holder will represent the OTL Technical Operations team to build strategic, mutually beneficial and aligned partnership/collaborations to ensure the on-time delivery of the OTL Technical Operations team objectives. The ability to relationship shape at the strategic level whilst ensuring the delivery of the functional team objectives in both organisations is essential.

Responsibilities:

Tactical:

  • Develop a strong understanding of the CDMO’s organisational structures and relationships with other key stakeholders. Maintain high visibility within the CDMO organisation and a positive CDMO relationship to drive successful business outcomes
  • Work with the Programme Managers and OTL subject matter experts (SME) on each CDMO team to manage the day to day relationship between the allocated CDMO and OTL.
  • Maintain close relationships with the OTL CDMO team to identifying potential issues before they arise.
  • Proactively set a cadence for contacts, meetings and follow-ups. Ensure all relevant meetings are formally recorded, circulated and acted upon.
  • Monitor the CDMO and the associated OTL’s Technical Operations team performance and provide evidence based, timely feedback and periodic reports to both organisations when required
  • Be the point of escalation for delivery issues and arrange for follow through of resolutions via the appropriate department/SME, reporting observations to the OTL Technical Operations senior management team when required. Lead and execute technical and business discussions on challenges and solutions
  • Build multi-level relationships with the relevant CMO teams/departments including those at executive level. Through constant engagement establish strong cross-company relations with key areas such, quality control, quality assurance, clinical and commercial teams and other core functions
  • Develop, coordinate and execute a strategic plan for managing the allocated CDMO; comply with this plan modifying and updating as required to ensure the successful achievement of differing product specific OTL timelines and milestones
  • Develop and maintain a broad, deep and long-term partner relationship with the allocated Contract Manufacturing Organisations (CDMOs) to facilitate OTL’s clinical and commercial programmes. Ensure seamless, on time delivery of OTL Technical Operations team milestones, on budget and to the agreed quality standards.
  • Become knowledgeable of the CDMO’s propositions, their business challenges and maintain updates to OTL Technical Operations of the latest developments
  • Assist with the negotiation, review and approval of MSA, QTA’s, technical and supply agreements with cross functional colleagues ensuring OTL’s ability to negotiate effective agreements meet business and financial demands and risk management targets
  • Lead efforts to increase alignment, mutual understanding, and trust between OTL Technical Operations teams and the CDMO
  • Work closely with OTL Supply chain and Commercial teams to facilitate manufacture and supply of gene-modified cell-based therapeutic products

Strategic:

  • Take a lead in analysing and presenting strategic opportunities while working in a collaborative fashion and in close partnership with SME’s
  • Other activities as may be assigned

Requirements

  • Proven track record and expertise in the development, manufacture or delivery of cell and gene therapy products.
  • Good working knowledge of FDA, EMA, GMP and ICH regulatory requirements
  • Proven relationship management experience in the biologics contract manufacturing or similar industry.

Skills & Abilities

  • Demonstrate a drive for results blending urgency, strategic thinking and an awareness of influencing behaviour in a global environment
  • Driven to deliver quality results on time and in a highly ethical and professional manner
  • Highly effective communicator able to build relationships throughout the organisational hierarchy, with strong oral and written communication skills
  • Must be comfortable operating in a demanding, fast paced environment and be capable of reacting swiftly to changing business demands
  • A good team player with a hands-on approach, able to quickly establish credibility, build rapport and trust and influence and maintain effective working relationships with co-workers, managers, and personnel from external organisations across multiple organisational levels
  • Resilient and able to work well under pressure, able to prioritise a heavy workload and work both reactively and pro-actively
  • Strong influencing and leadership skills; organised with strong initiative and creative problem-solving abilities
  • Keeps up to date with professional knowledge, expertise and best practice
  • Willingness to travel up to approximately 33% of time

Education

  • A minimum BSc or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences