Senior Process Engineer

Location: Toulouse, France

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Type of contract: Permanent

We’re looking for a passionate and curious Senior Process Engineer – New Product Introduction (NPI) to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a Senior Process Engineer-NPI at Sandoz Biologics, you have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity fuel both your personal growth and the success of the team.

What You’ll Do

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• Lead Upstream/ Downstream stakeholders New Product Induction process at J.POD Toulouse (Sandoz Biologics France) to support the start and rapid scale-up of commercial GMP manufacturing activities.
  
• Partner with Product and Process Design (PPD) to coordinate successful efficient scale-up and transfer operations and to ensure the successful integration of process knowledge into manufacturing operations.
  
• Partner with supply chain to support Upstream/ Downstream Bill of Material development and demand planning for new products.
  
• Partner with Engineering and Digital disciplines to conduct facility fit assessments and plans to support system updates needed for new product introduction.
  
• Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions for new product introduction.
  
• Partner with Quality, CQV and Global MS&T to develop and implement process validation and comparability study activities leading to successful product registration.
  
• Acting as a subject matter expert for regulatory and client inspection audits.
  
• Utilize the team’s technical skills and process knowledge to participate and/or lead investigations related to Upstream/ Downstream NPI activities. Collaborate with impacted groups to develop and execute effective CAPA.
  
• Apply Operational Excellence principles to lead continuous improvement in NPI activities.
  

Who You Are

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• Ph.D. or Master’s degree in relevant field or related program with 10+ years of pharmaceutical/biotech validation experience including a minimum of 3-5 years of experience leading a New Product Introduction program for GMP biopharmaceutical products (Technology Transfer).
  
• Excellent verbal and written communication skills in French and English; ability to interface with all levels of the organization.
  
• Technical mastery of cell culture, purification and solution preparation operations using disposable-based manufacturing technologies.
  
• Demonstrated leadership capabilities to build and mentor high-performing multi-disciplinary teams, drive change, and influence internal and external stakeholders.
  
• Knowledge and experience with late-stage clinical and commercial biologics drug substance manufacturing programs, including project leadership roles in process validation, PPQ, and commercial manufacturing.
  
• Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.
  
• Experience in developing submission packages for pharmaceutical product registration.
  
• Experience in audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.
  
• Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.
  
• Experience in client relations and communications.
  
• Excellent interpersonal, team, and collaborative skills are required. xuezdbg
  

ENG: In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.