Senior Process Engineer
Il y a 2 mois
Just-Evotec Biologics is seeking a highly motivated Downstream Senior Process Engineer - 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 interactions 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, 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.
Responsibilities:
- Reporting to the MSAT-NPI manager
- Contribute to leading 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 Process 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 to support the team for regulatory and client inspection audits.
- Utilize the team’s technical skills and process knowledge to participate in 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.
Requirements:
- Masters degree in relevant field or related program with 5-10 years of pharmaceutical/biotech validation experience including a minimum of 2 years of experience leading a New Product Introduction program for biopharmaceutical products (Technology Transfer).
- Experience with late-stage clinical and/or commercial biologics drug substance manufacturing programs, including process validation, PPQ, and potentially commercial manufacturing.
- Proven record of accomplishment in GMP pharmaceutical or biotechnology is required.
- Strong background and technical mastery of purification and solution preparation operations using disposable-based manufacturing technologies.
- Leadership capabilities to contribute to building of a high-performing teams, to drive change, and influence internal and external stakeholders.
- 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.
- Good 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 and other external auditors as an audit support staff.
- Familiar with 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.
- Ability to lead multi-disciplinary teams that span multiple organizations.
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