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