Director of Technical Operations in London

Allerton Bishop is searching on behalf of global biopharmaceutical company with UK headquarters in England. Our client is preparing for
commercial launch
of a biopharmaceutical product on a global scale and we are searching a
Director of Technical Operations
— a strategic technical leader responsible for late-phase clinical manufacturing, commercial readiness, and sterile drug product external manufacturing.

This role is mission-critical to ensuring successful development-to-commercial transition, overseeing complex CMO operations, and driving the technical execution required for global regulatory success.

Key Responsibilities

You will lead technical operations for a late-stage biopharmaceutical product, partnering closely with MSAT, CMC, Regulatory, and Quality to ensure seamless progression from clinical manufacturing, BLA readiness, and commercialisation.

• Partner with
  MSAT
  to implement product, process, and robust technical oversight.
• Lead
  end-to-end external sterile drug product manufacturing.
• Drive
  BLA readiness
  , including validation strategy, PPQ planning, and data package development.
• Oversee execution of
  commercial batch manufacturing
  in line with supply, quality, and regulatory requirements.
• Manage budgets, timelines, vendor performance, and program resources.
• Ensure
  GMP compliance
  across all development and commercial manufacturing activities.
• Support audits and inspections and contribute to regulatory submissions with strong documentation practices.

Experience & Expertise

You will be a seasoned biologics manufacturing leader with deep understanding of biopharmaceutical drug product operations.

Requirements include:

• Bachelor\’s degree in Engineering, Biochemistry, Pharmaceutical Sciences or related field;
  MS/PhD preferred
  .
• Expert knowledge of biopharmaceutical manufacturing with strong sterile drug product exposure.
• Proven track record in
  BLA preparation, PPQ, validation, and commercial launch
  .
• Strong preference for external manufacturing experience.
• Proven leadership, communication, and project management abilities.

Biopharmaceutical | Biologics | Sterile Drug Product | Late-Phase & Commercial Manufacturing | Technical Operations Director | Manufacturing Director