CMC & Process Excellence Leader

Euroapi; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

EUROAPI, leader en ingrédients pharmaceutiques actifs, recherche un leader en CMC et Excellence des Processus pour coordonner les efforts de R&D dans un environnement dynamique. Ce rôle clé inclut la formation des équipes, la gestion des soumissions réglementaires, et l'amélioration continue des flux de travail, axé sur l'innovation durable.

Qualifications

• Expérience en CMC, R&D, et développement de processus souhaitée.
• Compétences en gestion du changement et affaires réglementaires appréciées.

Responsabilités

• Coordonner les efforts entre les équipes de molécules et biotechnologie.
• Améliorer les flux de travail et former les nouveaux employés.
• Définir des stratégies de données pour les soumissions réglementaires.

Connaissances

Communication claire

Leadership

Pensée stratégique

Collaboration

Analyse

Curiosité

Formation

Diplôme avancé en chimie, sciences pharmaceutiques ou domaine connexe

Outils

Outils de gestion des connaissances

Description du poste

Join a centre of R&D excellence where we work passionately to develop, manufacture, and deliver active ingredient solutions for our healthcare partners around the world. You'll ensure we stay ahead of the innovation curve and lead the way in developing sustainably active pharmaceutical ingredients in Europe and beyond, to the highest quality standards.

EUROAPI is looking for a hands-on leader to drive CMC and Process Excellence across R&D. You’ll coordinate efforts across Small Molecules, Tides, and Biotechnology teams, support regulatory deliverables, and help build a strong knowledge-sharing culture. You’ll also lead initiatives to improve team workflows, train newcomers, and define smart data strategies for regulatory submissions.

Key Responsibilities

• Report to the Chief R&D Officer and be part of the R&D Leadership Team.
• Collaborate with the Head of Innovation and platform leaders to lead the integrated CMC and Process Excellence structure.
• Clarify roles and support regulatory submissions.
• Lead expert groups in chemical or biochemical synthesis, process development, analytics, and regulatory affairs.
• Align quality and regulatory strategies with cross-functional teams.
• Guide working groups to define and improve ways of working.

Training & Standards

• Identify skill gaps and implement targeted training programs.
• Create practical training materials and templates.
• Standardize onboarding processes for newcomers.
• Define acceptable risk levels to optimize data collection.

Community & Knowledge Sharing

• Assess and enhance expert communities to align with CMC objectives.
• Implement a nomination process for qualified participants and set meeting frequencies to promote engagement.
• Encourage best practices and continuous learning.
• Develop a knowledge management system to capture and share regulatory insights.

Key Skills

• Clear communication and ability to simplify complex topics.
• Empowering leadership and change management skills.
• Strategic thinking and systems mindset.
• Strong collaboration and stakeholder alignment abilities.
• Analytical and problem-solving mindset.
• Curiosity and openness to innovation.

Qualifications

• Advanced degree in Chemistry, Pharmaceutical Sciences, or related field.
• Experience in CMC, R&D, and process development.
• Strong leadership and change management skills.
• Experience in regulatory affairs, training, or scientific communication is a plus.
• Familiarity with knowledge management and AI tools is desirable.

About Our Company

EUROAPI focuses on reinventing active ingredient solutions to meet global healthcare needs sustainably. We are a leading active pharmaceutical ingredients provider with around 200 products and innovative molecules developed through our CDMO activities. With over 3,450 employees and six manufacturing sites across Europe, we supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris.

Culture & Values

Our culture emphasizes career development, talent management, and doing things right. We empower our people, prioritize customer value, and act responsibly to support the sustainability of the pharmaceutical supply chain. Our core values guide us in achieving our goals and fostering a resilient, responsible organization.