We are looking for a highly motivated, innovative & experienced microbial process development expert to lead a group within the Microbial Platform Upstream Processing organization, which is part of the Global CMC Development.
The successful candidate will establish a dynamic multi-disciplinary multi-modality upstream process development team, with responsibilities spanning from E. coli to yeast fermentation and delivering Synthorin®, Nanobody® and plasmid projects.
Responsibilities
- Lead direct reports, including scientist, engineers and technicians according to Sanofi values, ethics and security.
- Establish next generation microbial fermentation platforms enabling innovative microbial-based modalities, e.g. Nanobody®, Synthorin® and plasmid processes.
- Provide management and scientific support to team members, including lab heads, scientists, engineers, and technicians, and promote their career development.
- Provide scientific perspectives with respect to microbiology and molecular biology, microbial physiology, media development, and upstream process development as well as process scale-up required for early and late stage process development.
- Develop robust and cost-efficient process to support clinical supply and commercial launch
- Ensure appropriate documentation of process development activities and implement QbD principles in upstream processing along the development path.
- Develop processes in view of industrial needs for robustness and cost efficiency. Scale-up and transfer of established production process into pilot plant and commercial scale.
- Contribute to the implementation of predictive control strategies and PAT to prepare next generation real time release processes.
- Contribute to CMC project teams as E2E DS team representative in international teams.
- Close collaboration with Downstream Processing, BioProcess Engineering, Pilot plant, Bioanalytics, CMC project management and Industrial Affairs functions (commercial manufacturing) ensuring seamless process handovers
- Work closely and independently with counterparts in CMC Development and other functions along the value chain to deliver on CMC milestones while adhering to project timelines.
- Build efficient interactions with collaborators within and outside the company and leverage the SME network to evolve our development approach
- Actively push for appropriate communication of results inside and outside the company by patents, publications, and presentations.
Requirements
- Ph.D. (or comparable) in microbiology, biochemistry, biotechnology or biochemical engineering with at least 5 years of industry experience in microbial (E. coli and/or yeast) process development. Alternatively, a relevant master's degree with minimal 10 years of experience may be considered.
- Strong understanding and expertise on optimization, scale up and tech transfer of microbial processes.
- Experience in leading Drug Substance development teams.
- Scientist who understands leading teams within digitalized environment - open minded to create a workplace for the next generation scientists within the framework of Sanofi strategy with new culture - diversity and company values.
- Understanding the regulatory requirements and proven track record in IND/IMPD and BLA filing.
- Minimal 3 years of people management or matrix management experience with a strong track record of creating high performing teams.
- Excellent interpersonal and communication skills with strong emphasis on working in teams.
- Can do and will do attitude
Our offer:
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
- An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
- An individual and well-structured introduction and training of new employees.
- You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
- As a globally successful and constantly growing company, Sanofi provides international career paths as well.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.
