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