MSAT Process Expert Lead

Exprimez votre talent avec nous !  

Vous voulez explorer, franchir des obstacles, faire des découvertes ? Nous savons que vos projets sont ambitieux. Les nôtres aussi ! Dans le monde entier, nos collègues ont la passion de l’innovation scientifique et technologique qui enrichit les vies humaines grâce à nos solutions dans les domaines Healthcare, Life Science et Electronics. Ensemble, nous voyons grand et avons à cœur de prendre soin de notre large diversité de collaborateurs, clients, patients et de la planète. C’est pourquoi nous sommes toujours à la recherche d’esprits curieux qui souhaitent imaginer l’impossible avec nous.

Tous unis pour les patients : l’objectif de la branche Santé est de contribuer à créer, améliorer et prolonger des vies. Nous développons des médicaments, des dispositifs intelligents et des technologies innovantes dans les domaines thérapeutiques tels que l’oncologie, la neurologie et la fertilité. Nos équipes travaillent sur les 6 continents avec passion et curiosité dans le but d’aider les patients à tous les stades de leur vie. Rejoindre notre équipe Santé signifie participer à une culture professionnelle diversifiée, ouverte et flexible offrant de belles opportunités pour le développement personnel et l’évolution de carrière à travers la planète. 

Your role: The MSAT Expert Lead is responsible for providing high-quality technical and scientific support for biotech and F&F production and packaging operations. This role involves leading a team of MSAT experts and lab personnel, including the management of the MSAT Drug Substance (DS) lab and lab team, as well as the Drug Product (DP) and Finished Product (FP) process experts. The MSAT Expert Lead is dedicated to improving commercial processes through various initiatives such as process optimization, new technology evaluation, product contact raw material implementation, troubleshooting, and supporting technology transfer activities.

Key Responsibilities

• Team Leadership: Manage and supervise a team of approximately 12 MSAT experts and lab personnel, ensuring effective communication and collaboration within the unit and with other departments. Focus on the development of the lab and expert team to establish them as true experts in DS, DP, and FP processes on site, and elevate the MSAT lab to be a key support tool for the site.
• Lab Management: Oversee the operations of the MSAT DS lab, ensuring that lab activities align with production goals and adhere to quality standards.
• Process Optimization: Conduct studies to enhance commercial processes, including life cycle management and the implementation of new technologies.
• New Technology Evaluation: Assess and implement new technologies to improve efficiency and effectiveness in production processes.
• Raw Material Implementation: Oversee the implementation of product contact raw materials in compliance with quality standards.
• Troubleshooting: Lead troubleshooting efforts to resolve complex issues impacting production and quality.
• Compliance Management: Ensure adherence to Good Manufacturing Practices (GMP) and other regulatory requirements, maintaining high standards of quality and safety.
• Training and Development: Define training needs and oversee the professional development of team members, ensuring they meet established competencies.
• Cross-Functional Collaboration: Work closely with internal MSAT departments (SPM, Validation Group) as well as site departments (Quality, Validation, Engineering, Digital Operations) and external stakeholders (GMSAT, PQL, Guidonia Quality Unit, etc.) to support inspections, investigations, and process validation.
• Problem Solving: Proactively identify potential issues affecting operations and coordinate rapid resolution strategies.

Who you are:

Qualifications

• Education: Degree in Biotechnology, Process or Bio-Engineering, Pharmacy, or a related field.
• Experience: Minimum of 10 years in a manufacturing environment, preferably within international pharmaceutical or biotech companies, with a strong emphasis on Drug Substance (DS) or Drug Product (DP) process expertise.
• Skills:
• In-depth knowledge of GMP standards and regulations.
• Technical expertise in pharmaceutical production principles and quality systems.
• Proficient in project management tools and methodologies.
• Strong communication skills in both French and English (fluent in writing and speaking).

Personal Attributes

• Purposeful and results-driven with a collaborative mindset.
• Innovative thinker who is future-oriented and empowering to team members.
• Ability to navigate complex situations and influence stakeholders effectively.

Area of Impact

The MSAT Process Expert Lead will influence and coordinate efforts to align the unit’s objectives with broader manufacturing goals, ensuring the continuous improvement of processes and maintaining the inspectability status of the unit.

Join us at BioPharma Aubonne and play a crucial role in advancing our mission to deliver high-quality biologics to the market. If you are ready to take on this exciting challenge, we invite you to apply!

Ce que nous offrons : nous sommes des esprits curieux, issus d’horizons variés et de perspectives et d'expériences de vie diverses. Nous croyons que cette diversité stimule l'excellence et l'innovation, renforçant ainsi notre capacité de leader dans les domaines de la science et de la technologie. Nous nous engageons pour que toutes et tous aient accès à des opportunités de développement et pour que chacun avance à son propre rythme. Rejoignez-nous pour construire une culture d'inclusion et d'appartenance qui impacte des millions de personnes et permet à chacun d’accompagner le progrès humain !

Postulez dès maintenant et devenez membre de notre équipe dont la vision est de stimuler les découvertes pour élever l'humanité !