1. Our position

MSAT Senior Scientist – Analytical Lead

• Locationg: Geel
• Limited Remote working and up to 10% of travel expected
• Job type: Permanent
• Function in day shift (flexible working hour system), 40-hours/week.

2. About the job

Our Team:

The Analytical Lead is a member of the Analytical Science and Technology (AST) team in the Recombinant Mammalian Drug Substance (DS) function within the global Manufacturing Science, Analytics and Technology(MSAT) organization and is based in Sanofi Geel biopharmaceutical manufacturing site. The Recombinant Mammalian DS platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture-based DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing/Quality Control support. The function is responsible for tech transfer activities including fit-gap assessment, validation, dossier sections preparation, & PAI support to enable launch of new and LCM products. Our expansive portfolio covers multiple products, modalities and expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20+ new products in next 3-5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates, synthorins and nanobodies. We are pursuing future innovations such as digital labs, factory of future and advanced analytics based process understanding and control.

The opportunity:

Starting from thorough scientific and technical knowledge the Analytical Lead coordinates analytical technology transfer activities aiming at introduction of new products and accompanying processes/analytics at the Sanofi biomanufacturing sites. You operate as part of the MSAT AST team in close collaboration with the CMC/technical product and QC team(s). You are responsible for the analytical aspects of one or more products and therefore you will closely interact with process-oriented teams. You operate in a matrix organization together with a team of analytical experts. You keep the overview and leads the required activities to successful completion. The activities are phase-appropriate for products in either late development (clinical) or commercial phase.

Main responsibilities:

• End-to-end analytical representative and primary MAST AST contact person the assigned product or product families. Accountable for E2E product analytical strategy and ALCM plan, in alignment with associated functions such as QC.

• Coordination of analytical technology transfer for products in commercial, next-generation, and late development phase. Definition of analytical lifecycle management activities, harmonization on analytical technologies, leading specification setting and comparability studies for the assigned products and programs. Participation in the development and implementation of a product control strategy and process related investigations

• Leading complex method/product investigation in close collaboration with other functions within and outside of MSAT e.g. quality, CMC, RA, R&D, manufacturing as well as with external partners. Communication of timelines and risks to stakeholders and the teams

• Support of process and analytical changes via, amongst others, analytical gap assessment, product risk assessments in conjunction with process experts and QC representatives

• Sharing of technical knowledge in the global MSAT organization and beyond. Dedicated to improve analytical methods in support of product release and extended product knowledge gathering upon interaction with the analytical experts. Establishment of subteam of experts for the assigned products

• Coordination of section authoring in support of new product launches of changes to the dossier of commercial products. Supporting internal and external inspections

3. About you

Required Skills & Qualifications:

• You have a PhD or master in Life Sciences, with relevant experience of minimum 5 years, in Analytics or MSAT-like functions

• Since all writing is in English and given the international context, you are a fluent English writer/speaker

• You have specific experience at all steps in the analytical method lifecycle (i.e.method development, validation/transfer, execution, spec setting), specification settings and product comparability programs.
  Experience with production processes, cell culture or purification, is a plus

• You are flexible, willing to adapt to changing priorities and willing to learn at a rapid pace

• You are a great motivator and can coach people to success

• You are a strong communicator, who is able to connect, go in discussion and find compromise with stakeholders, the analytical team and people in other departments or sites

• You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail.

• You have a strong knowledge of quality (cGMP) and regulatory guidelines

• You are familiar with various statistical and data trending techniques

• You like to work in team and consider yourself to be a good team player

Preferred profile:

You have a master in life sciences, engineering of equivalent, PhD with ≥ 5 years of experiance in Biologics development, bioprocessing engineering and/or commercial manufacturing operations.