Job Title:
Global Process Science Lead – Project Delegate
Project Overview:
We are seeking a highly skilled Global Process Science Lead to support critical technology transfer activities for a biologics large molecule project in South America.
Your Key Responsibilities:
1. Represent the process owner for a biologics large molecule in the hematology area, ensuring site readiness for engineering and PPQ runs.
2. Support decision-making at local and site levels from a global perspective, driving the creation of TT documentation following company methodology.
3. Act as a senior technology consultant, connecting with site project teams and external business partners to explain critical process steps and manufacturing know-how.
4. Develop gap assessments and mitigation strategies in collaboration with Process Science Leads and subject matter experts.
5. Review and assess risks in documents to support various TT phases, including PQ, PPQ, and manufacturing activities.
Your Background:
We are looking for an individual with:
* A minimum MSc in Biotechnology or a related field.
* Extensive expertise in DS (Cell Culture and Purification) and DP (Filling, Lyophilization).
* Proven experience in PPQ and technology transfer projects.
* Seniority and maturity in technical expertise, with strong stakeholder interaction skills.
* Ability to work autonomously while effectively contributing to team and matrix environments.
What's on Offer:
This is an exciting opportunity to lead impactful projects within a global and matrixed environment, expand your expertise in biologics, technology transfer, and process readiness, and work with a leading global pharmaceutical company.