Director of Msat

il y a 4 jours

Toulouse, France Evotec Temps plein

Director of MSAT (Manufacturing Sciences and Technology) - all genders

Project Background and Objectives:
Just-Evotec Biologics EU is currently in the startup phase of a new biologics manufacturing facility (J.POD Toulouse). In parallel, the global MSAT organization is undergoing structuration. The Director of MSAT will be responsible for securing the operational readiness and ramp-up of the local MSAT team, while aligning with the broader MSAT strategy of Just-Evotec Biologics.

This role is critical to ensuring timely delivery of technical support to GMP production, while managing complex technology transfers and coordinating with global stakeholders.

Mission Purpose:

- Structuring and leading the MSAT function at J.POD Toulouse during the facility’s start-up phase.
- Ensuring operational continuity and efficient technical support to the Production team, with a strong focus on compliance, process robustness and deviation management.
- Supporting and coaching a team of ~15 MSAT engineers and managers, helping them gain autonomy and maturity in a context of high complexity and limited seniority.
- Managing and de-risking the technology transfer of the first commercial biosimilar project from Redmond (US) to Toulouse, in full compliance with GMP and within project-defined timelines.
- Acting as the technical interface with the Process & Product Development (P&PD) teams to ensure proper integration of process knowledge and lifecycle data into site execution.
- Collaborating closely with QA, QC, Engineering, and Production to ensure seamless GMP readiness and execution.
- Acting as a key interface with the Global MSAT organization, ensuring alignment on roles, deliverables, governance and reporting.

Expected Deliverables:

- 30/60/90-day roadmap with key priorities and metrics.
- Full diagnostic of MSAT readiness and team capabilities, with risk register and mitigation plan.
- Team routines and governance: visual management, issue escalation, KPI tracking, technical reviews.
- Transfer readiness plan for the Redmond-to-Toulouse biosimilar project, including gap assessments, timelines, and risk mitigations.
- Support to analytical comparability efforts with input into experimental design and interpretation.
- Process fit evaluation and tech transfer documentation package aligned with internal and regulatory expectations.
- Regular executive updates and risk dashboards to JEB EU leadership and Global MSAT.

Profile and Presence Required:

- Strong expertise in biologics process development and manufacturing (USP/DSP/formulation), including GMP and regulatory frameworks (FDA/EMA).
- Proven leadership in structuring MSAT teams, preferably in a CDMO or multi-site biotech environment.
- Demonstrated experience in technology transfer of commercial biologics across sites.
- High on-site presence in Toulouse expected (minimum 4 days/week).
- Fluent English required, experience working with US-based teams and global stakeholders preferred.

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