Operations Director
2 weeks ago
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.
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.
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.
Bachelor’s degree in Engineering, Biochemistry, Pharmaceutical Sciences or related field; MS/PhD preferred .
Proven track record in BLA preparation, PPQ, validation, and commercial launch .
Proven leadership, communication, and project management abilities.
Biopharmaceutical | Biologics | Sterile Drug Product | Late-Phase & Commercial Manufacturing | Technical Operations Director | Manufacturing Director
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