Director of Technical Operations
20 hours 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.
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
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