Principal Scientist CMC

26/07/21

Location

Technologiepark-Zwijnaarde 21, Gent, Belgium

Function type

Downstream process development & technologies

Vacancy

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 aspects involved in the discovery and pre-clinical development of biological 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 able 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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