Scientist II Purification (Pilot)
Evotec
Toulouse, France
What You’ll Do:
Pilot-Scale Operations & Execution:
- Execute and support pilot-scale downstream unit operations, including bioreactor runs up to ~50 L, for engineering, scale-up, and material generation batches;
- Translate laboratory-scale downstream process parameters into pilot-scale execution under guidance, ensuring process robustness, reproducibility, and data integrity;
- Support pilot activities that bridge process development and cGMP manufacturing, including preparation for tech transfer.
Study Support & Cross-Functional Collaboration:
- Collaborate closely with USP pilot, DSP development, Analytical, and Manufacturing teams to support pilot-scale material generation for process characterization, equipment qualification, and other material generation (e.g., toxicology, stability);
- Participate as an downstream pilot representative on cross-functional project teams, contributing to planning and execution aligned with project timelines.
Facility & Operational Readiness:
- Support day-to-day pilot operations, including equipment setup, preparation, cleaning, and turnover;
- Ensure activities are conducted in compliance with safety, quality, and operational standards;
- Assist with scheduling and readiness activities in coordination with senior team members.
Pilot Optimization & Technology:
- Support the implementation and optimization of intensified or advanced upstream processes at pilot scale, including the use of single-use systems and automation tools;
- Collect, review, and interpret pilot-scale process data to support process understanding and improvement.
Documentation & Compliance:
- Accurately document pilot operations, process data, and observations in batch records, protocols, and reports;
- Author and review SOPs, protocols, and technical reports under guidance;
- Support deviation documentation and investigations as needed.
Technical Contribution & Knowledge Sharing:
- Act as a technical contributor for downstream pilot execution, including scale-up principles and process control strategies;
- Support preparation of tech transfer documentation to manufacturing;
- Communicate pilot study objectives, execution status, and results clearly to project teams and management.
Training & Team Support:
- Support training of junior staff and technicians on pilot-scale DSP operations, safety practices, and standard procedures;
- Promote a strong culture of safety, data quality, and scientific rigor.
Vendor & Equipment Support:
- Support interactions with equipment vendors and engineering teams for equipment setup, troubleshooting, and optimization.
Your profile:
- Master’s in engineering, Biochemistry, Biology, or related field with 5+ years of experience or Ph.D. in Engineering, Biochemistry, Biology, or related field. Bachelor's with more than 10 years of experience;
- Proficiency in both verbal and written English is essential;
- Excellent attention to detail, able to stay organized and relaxed in complex situations while keeping track of multiple tasks and data;
- Experience in pilot-scale operations (10–200 L upstream scale);
- Understanding of scale-up principles, process control, and data interpretation for both upstream and downstream processes;
- Experience supporting engineering batches, material generation, and technology transfer to cGMP manufacturing;
- Proven ability to lead multidisciplinary teams, manage pilot facilities, and coordinate cross-functional projects;
- Experience in biosimilar or biologics development programs is an advantage;
- Experience working in or supporting a cGMP or cleanroom environment;
- Familiarity with process and equipment qualification (IQ/OQ/PQ);
- Understanding of process safety and risk assessment principles in pilot-scale bioprocessing.
Pluses
- General understanding of cell culture, protein chemistry, and bioprocess engineering fundamentals.
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