Job Description

Overview:
Expleo offers a unique range of integrated engineering, quality, and strategic consulting services for digital transformation. Against a backdrop of unprecedented technological acceleration, we are the trusted partner for innovative companies. We help them develop a competitive advantage and improve the daily lives of millions of people

To support our growth in Switzerland, we are looking for a consultant:

External Manufacturing Operations Lead - Biologics

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Position Summary

We are looking for an

External Manufacturing Operations Lead Consultant

to oversee and support the management of Contract Manufacturing Organizations (CMOs) involved in the production of biological drug substances.
The role ensures supply continuity by guaranteeing quality, compliance, timelines, and cost efficiency, while building strong and long-term partnerships. Responsibilities cover both clinical and commercial supply within a GMP-regulated environment.

Key Responsibilities

Oversee external production and ensure timely supply of biological drug substances. Manage planning, budgets, KPIs, and GMP documentation to maintain compliance. Maintain regular and effective communication with CMOs and coordinate technical issue resolution. Contribute to long-term sourcing strategies and contractual management (MSAs, Quality Agreements, risk assessments). Lead technical projects including tech transfers, process validations, and continuous improvement initiatives. Draft, review, and approve regulatory and technical documentation related to manufacturing.

Profile

Master's degree in Science, Engineering, or related field. At least 2 years of experience in the biopharma/biotech industry, ideally in manufacturing or QA. Knowledge of biological processes (fermentation, purification) and GMP regulations. Experience managing outsourced activities and technical projects is a strong asset. Strong communication, leadership, and budget management skills. * Analytical mindset with a proactive, problem-solving approach.