Scientist II Pilot

Scientist II Pilot

Evotec

Toulouse, France

What You’ll Do:

Pilot-Scale Operations & Execution:

• Prepare and run pilot scale single use bioreactors and related equipment, and provide operational support on bioreactor specifications, operation, process parameters
• Execute and support pilot-scale upstream unit operations, including bioreactor runs up to ~50 L, for engineering, scale-up, and material generation batches.
• Translate laboratory-scale upstream 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 DSP pilot, USP 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 upstream 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:

• Collaborate in the technical definition of projects of introduction of new technologies and equipment.
• Support process improvement and process optimization of intensified or advanced upstream processes, including the use of single-use systems and automation tools.
• Collect, analyze, review, and interpret pilot-scale process data to support process understanding and improvement.
• Conduct kLa (oxygen transfer) studies to characterize bioreactor performance, assess mass transfer capabilities, and support process transfer across scales and equipment types.
• Lead and contribute to scaleup activities, ensuring robust translation of upstream processes from laboratory/pilot scale to manufacturing scale using engineering principles (e.g., kLa, P/V, tip speed, mixing time).
• Evaluate new bioreactors, including characterization of hydrodynamics, mass transfer, mixing performance, and compatibility with existing upstream processes and facility constraints.

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 upstream pilot execution, including scale-up principles and process control strategies.
• Support preparation of tech transfer documentation to manufacturing.
• Communicate clearly and effectively with cross functional and external stakeholders about pilot study objectives, execution status, and results clearly to project teams and management.

Training & Team Support:

• Mentor and support training of junior staff and technicians on pilot-scale USP operations, safety practices, and standard procedures.
• Promote a strong culture of safety, data quality, and scientific rigor.

Vendor & Equipment Support:

• Initiate and support interactions with equipment vendors and engineering teams for equipment setup, troubleshooting, and optimization.

Who You Are:

• 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 USP (cell culture), protein chemistry, and bioprocess engineering
• Hands-on experience in pilot-scale bioreactor operations (10–200 L).
• Expertise in 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.
• Experience working in or supporting a cGMP or cleanroom environment (job is in a non-GMP environment).
• Familiarity with process and equipment qualification (IQ/OQ/PQ).
• Understanding of process safety and risk assessment principles in pilot-scale bioprocessing.
• Proficiency in both verbal and written English is essential.

Pluses:

• Experience in biosimilar or biologics development programs is an advantage.
• Experience in production of monoclonal antibodies is a plus
• Excellent attention to detail, able to stay organized and relaxed in complex situations while keeping track of multiple tasks and data.