Principal Scientist CMC

Job content

Principal Scientist CMC

About The Opportunity

Join Ablynx, a Sanofi company, as a Principal Scientist involved in early CMC development and CMC project management. In this cross-functional role, you will be responsible for overseeing all early CMC activities for a novel type of therapeutic Nanobody® molecules produced using semi-synthetic technology.

Each day you get a chance to contribute, to develop your skills and experience but also to be part of a young, fast moving and international company.

About Ablynx

At Ablynx (Ghent, Belgium), a Sanofi company, we discover and develop Nanobody® molecules, a novel class of therapeutic proteins based on single domain antibody fragments. Nanobody® molecules make a big difference in the treatment of serious human diseases. No wonder our people are so motivated to give their best.

The CMC Department is responsible for all non-GMP activities to support Nanobody® developability assessments and pre-clinical CMC development activities.

About Growing With Us

In this role you will provide scientific and collaborative leadership for the R&D activities and deliverables of an intradepartmental team within the scope of assigned project activities, including:

• CMC developability assessment on lead candidates
• Host creation and cell bank generation (microbial expression systems)
• Development of upstream and downstream (chromatography and TFF) processes to ensure delivery of robust, scalable and cost-effective manufacturing processes that meet or exceed target product profile
• Non-GMP manufacturing up to 400L scale, including single-use technology
• Transfer of manufacturing processes to GMP manufacturing facilities (within Sanofi or to CMO)
• Development of stable liquid formulations
• Method development and qualification
• Stability studies
• In process monitoring and control
• Physico-chemical characterization of Nanobody® molecules and characterization of product related variants
• In-use stability and compatibility
• Comparability studies
• Report about the results and progress to the project team, management and/or other internal stakeholders
• Collaborate with research staff and other scientific members of the team and make strong individual contributions to the project.
• Contribute to the strategy of projects as a CMC member in transversal project teams, including Research, pre-clinical Pharmacology, DS/DP Manufacturing, QA, QC and Regulatory Affairs
• Prepare high level reports, summaries, manuscripts and other documents as appropriate
• Be up to date with the relevant regulatory guidelines and state-of-the-art in CMC, drive continuous improvement and define new strategies, technology or methods accordingly
• Optional: line manager of a team of Associate scientists
  
  

About You

Qualifications/Education & work experience

• PhD. in Life Sciences, Biochemistry or equivalent with 5+ years relevant CMC experience
• Experience coordinating of aspects involved in the discovery and pre-clinical development of biologic drugs
• Experience in microbial process development and manufacturing of biologics (E. coli, yeast, …)
• Experience in physico-chemical analysis of biologicals and knowledge of different analytical techniques
  
  

Competencies

• Superior organizational skills, with a strong track record as coordinator of critical path activities with internal stakeholders and/or external partners
• Ability to appropriately manage and prioritize a diverse workload
• Detail oriented, yet ability to keep the big picture in mind
• Solution-oriented problem solver
• Ability to work under pressure to meet deadlines and solid multitasking skills
• Excellent oral and written communication skills with the ability to clearly explain complex issues to diverse audiences
• Ability and desire to work in a fast-paced, dynamic environment
• Team player, enthusiastic and flexible
  
  

The motivation letter and the CV of the applicant must be in English, and include a paragraph specifying the technical expertise.

Inspire your Journey, what Sanofi can offer you:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
• An individual and well-structured introduction and training when you onboard
• 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
  
  

Please check this video to hear from Vivek Verma, Genzyme Head of Medical Affairs, Europe: https://vimeo.com/user41441921/review/517309099/57ecc96494

This is our Sanofi, Discover yours.

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