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Senior Manager, Purification Process Development
il y a 9 heures
Senior Manager, Purification Process Development
Location : Toulouse, France
**Department: Process & Product Design
Reports To: Director Process Sciences
We're 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 You'll Do**
- Leading a diverse group of scientists encompassing all aspects of purification process development, characterization, and validation as well as technology transfer to cGMP manufacturing for hybrid and continuous processes.
- Serving as an internal technical resource for cGMP manufacturing and Process Design as well as a resource and subject matter expert for external clients and partners for cell culture and bioreactor processes (small scale models, process transfer, and scale up) and authoring CMC regulatory sections.
- Collaborating across the organization to accelerate clinical development timelines while reducing development costs.
- Clearly and effectively communicating scientific information, experimental plans, and data to internal project teams, senior management, external clients, vendors, and technology development collaborators as well as the external scientific community such as regulatory agencies, review boards, and conferences.
- Independently designing, executing, and analyzing statistically designed experiments (DOE).
- Authoring SOPs, reports, and slides which summarize, organize, and interpret experiment results with review by appropriate team members.
- Working with vendors and manufacturers in developing, ordering, and troubleshooting equipment prototypes.
- Training, mentoring, and supervising staff and interns.
- Driving technology development for process intensification and continuous manufacturing to reduce manufacturing costs and footprint through improvements in culture productivity, control of product quality, and data management.
- Supporting the management of staff, capital resources, and planning within the department.
Who You Are
- Expertise in purification technology and process development, transfer to cGMP manufacturing plants, and authoring CMC sections of regulatory filings.
- Experience in Biosimilar development.
- Experience with commercial process development, process characterization, and validation.
- Expertise in design of experiments (DOE) and statistical analysis.
- Experience in training, mentoring, and supervising team members as well as leading development teams for external client projects and collaborations and internal technology development initiatives.
- Experience with high throughput process development systems is a plus
Pluses
- Experience analyzing data in tools such as JMP, R, or Python.
- General understanding of cell biology, fluid dynamics, mechanistic modeling for chromatography, and protein chemistry as well as knowledge in other functional areas (upstream and analytical sciences).
- Experience working in a cGMP or clean room setting (this job is non-GMP but knowledge of GMP is helpful for process/tech transfer activities)
- Master's degree in engineering, Biochemistry, Biotechnology or related field with 12+ years of experience or PhD with 10+ years of experience.
- Proficiency in both verbal and written English is essential.
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.
