Process Engineer
il y a 2 semaines
Just Evotec Biologics EU is seeking a highly skilled Downstream Process Engineer 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 – from project initiation through process validation and registration activities.
The ideal candidate will have a strong background in purification and solution preparation operations using disposable-based manufacturing technologies.
Responsibilities:
- 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.
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.
- 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.
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.
Just Evotec Biologics EU is an equal opportunities employer and welcomes applications from all qualified candidates.
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