Were excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive agile company culture. Join us to help make healthcare fairer and faster help us to pioneer access to medicine! Click to learn more.
What Youll 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 :
Masters in engineering Biochemistry Biology or related field with 5 years of experience or Ph.D. in Engineering Biochemistry Biology or related field. Bachelors 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 (10200 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.
Why Sandoz
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz a leader in this sector touched the lives of almost 500 million patients last year and while we are proud of this achievement we have an ambition to do more!
With investments in new development capabilities state-of-the-art production sites new acquisitions and partnerships we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost high-quality medicines sustainably.
Our momentum and entrepreneurial spirit is powered by an open collaborative culture driven by our talented and ambitious colleagues who in return for applying their skills experience an agile and collegiate environment with impactful flexible-hybrid careers where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
FR : Dans le cadre de sa politique Diversité Evotec étudie à compétences égales 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:
IC
Evotec is a global biotechnology company committed to advancing drug discovery & development together with our partners for medicines that matter.