J&J Family of Companies Fill & Finish Process Specialist in Leiden, Netherlands
The individual operates at the technical interface with external partners. The main responsibility is to ensure proper and timely execution of outsourced manufacturing activities as defined in SOWs, in compliance with applicable quality standards. In addition, the individual is accountable and responsible for Process-Fit-2-Plant activities (in case of external partners), including confirmation and technology transfer runs.
Furthermore, the individual is accountable and/or responsible for (parts of) outsourced process development, optimization, characterization and validation. These responsibilities will often be outsourced, preferably to the CMO that has been selected for manufacturing.
Accountable for proper and timely execution of outsourced manufacturing activities as defined in SOWs
Responsible for establishing and maintaining a trustful and professional relationship with the external partner
Responsible to participate in DPD sub team, ensuring alignment with project needs through Technical Integrator
Contribute as required to CMO selection process (accountability/responsibility at Head of Production)
Responsible as technical SME for alignment with QA
Responsible for technical input for QAA, MSA and related SOWs
Responsible for the process description and Process-Fit-2-Plant activities, including confirmation and technology transfer runs
Responsible for review of the documentation prepared by the external partner that is required for manufacturing, and bringing it to the required quality level – ensuring the correctness of the documentation and ensuring a smooth flow through the Crucell QA system
Responsible for assessing the technical readiness of the external partner prior to starting manufacturing (accountability Head of Production)
Technical oversight manufacturing
Being physically present at the external partner during execution of key manufacturing step (person-in-plant), resolving issues on the spot and guiding corrective measures if required.
Responsible for informing/escalating timely to the Technical Integrator and the Head of Production, and SMEs as needed
Responsible for evaluating process performance and costs, providing input for CMO oversight metrics and process development, and sharing best practices with peers
Responsible for closing deviations and CAPAs, ensuring aligned expectations between Crucell and the external partner
- Accountable and responsible for process development, optimization, characterization and validation (including writing study plans and reports), and/or accountable and responsible for outsourcing of these activities to external partners
Additional responsibilities for senior function
Responsible for identifying and implementing improvements in the way of working
All-round expert in quality, regulatory, technical and business aspects of external manufacturing
Responsible for coaching more junior colleagues
Key Performance Indicators:
Delivery of assigned project deliverables in full as planned, most importantly pre-clinical and clinical batches
Pro-active identification of issues, problem-solving capabilities, and timely implementation of solutions at external partner
Number of major and critical issues encountered during manufacturing, and in QA reviews of documentation
Trust and professionalism in relationship with external partner
Good judgment when to travel and when not
Communication skills, including conflict prevention/handling
Adherence to TI model (communication, escalation, project alignment)
Successfully implemented improvements (senior)
Being up to date with latest developments in quality, regulatory, technical and business areas (senior)
Specific professional/technical requirements:
Education: MSc/BSc or equivalent
In-depth understanding of GMP manufacturing of vaccines and/or large molecules, including relevant unit operations, equipment and facility design, as well as applicable regulatory guidelines.
At least 5 (10 for senior) years experience in vaccine and/or large molecule process development and/or manufacturing. Experience with the following is a strong advantage: process development, technology transfers, GMP manufacturing, outsourcing, troubleshooting, conducting audits and due diligence visits. For senior function: broad experience in applicable quality, regulatory, technical and business aspects.
Independent on location, flexible, collaborative, communicative and motivating, enjoys working in a team. Is able to travel frequently (25%) and stay abroad for up to 2 weeks. Interpersonal skills and business acumen are key for this position.
Janssen Vaccines & Prevention BV (8852)