Director of MSAT (Manufacturing Sciences and Technology) - all genders
Director of MSAT (Manufacturing Sciences and Technology) - all genders
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Job Description
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 ( 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 Toulouse during the facilitys 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.
FR : Dans le cadre de sa politique Diversit Evotec tudie comptences gales toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy Evotec considers with equal competences all applications including people with disabilities.
Required Experience:
Director
Employment Type
Full-Time
