MSAT NPI Process Validation PPQ

Job Title: MSAT NPI Process Validation PPQ

Location: Toulouse
Department: : MSAT
Reports To: Senior Manager-NPI

We're excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine 

What You'll Do:

• Lead Upstream/ Downstream stakeholders for Process Validation at J.POD Toulouse to support commercial GMP manufacturing activities.
• Acting as a subject matter expert and as a leader for PPQ preparation and execution.
• Partner with Product and Process Design, Quality, CQV and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.
• Partner with Product and Process Design and with with Manufacturing to coordinate successful efficient scale-up and technology transfer to ensure the successful integration of process knowledge into manufacturing operations.
• Partner with Supply Chain and with Manufacturing to support Bill of Material definition and to develop high-quality batch records, innovative and robust processes
• 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 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:

• Ph.D. (or Masters) degree in relevant field or related program with years of pharmaceutical/biotech validation experience including a minimum of 3-5 years of experience leading process validation program, PPQ, and commercial manufacturing for biopharmaceutical products.
• Demonstrated leadership capabilities to build and mentor high-performing multi-disciplinary teams, drive change, and influence internal and external stakeholders in GMP pharmaceutical or biotechnology
• 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.
• Technical mastery of cell culture, purification and solution preparation operations using disposable-based manufacturing technologies.
• Excellent interpersonal, team, and collaborative skills are required.
• Excellent verbal and written communication skills in French and English; ability to interface with all levels of the organization.

Why Sandoz? 

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more 

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. 

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged 

The future is ours to shape 

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

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