Senior Process Engineer - New Product Introduction (NPI) - Downstream
Just-Evotec Biologics is seeking a highly motivated Senior Process Engineer Downstream - New Product Introduction (NPI) to join a fast-paced, collaborative, and multidisciplinary team to lead activities related to the introduction of new products to the J.POD Toulouse biotherapeutics manufacturing facility. The role will provide cross-functional leadership for all phases of Just-Evotec’s NPI process – stretching from project initiation through process validation and registration activities.
The role will require close collaboration with all functional areas of the J.POD Toulouse team – including Product and Process Design, Process Engineering, Process Automation, Facilities Engineering, Quality Controls, Quality Assurance, Supply Chain, Manufacturing, Digital and EHS. The role will participate in client facing meetings to discuss topics related to NPI activities. The role will also collaborate with Just-Evotec Global MSAT, Client Program Managers, Global Supply Chain for client projects and continuous improvement efforts.
- Reporting to the MSAT-NPI manager
- Lead Downstream stakeholders NPI process at J.POD Toulouse to support the start and rapid scale-up of commercial GMP manufacturing activities.
- Partner with Product and Process Design 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 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 MSAT 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 Downstream NPI activities. Collaborate with impacted groups to develop and execute effective CAPA.
- Apply Operational Excellence principles to lead continuous improvement in NPI activities.
- Ph.D. (or Masters) degree in relevant field or related program with 10+ (15+) years of pharmaceutical/biotech validation experience including a minimum of 3-5 years of experience leading a New Product Introduction program for biopharmaceutical products (Technology Transfer).
- Extensive 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.
- Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
- Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies
- Demonstrated leadership capabilities to build and mentor high-performing teams, drive change, and influence internal and external stakeholders
- Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing
- Good 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
Additional Preferred Qualifications:
- 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 developing submission packages for pharmaceutical product registration
- Experience in client relations and communications.
- Demonstrated success in leading multi-disciplinary teams that span multiple organizations
- Entrepreneurial drive to achieve business objectives.
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.