J&J Family of Companies Fill & Finish Process Specialist in Leiden, Netherlands

Main purpose:

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.

Key responsibilities:

  • 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

Manufacturing-related

  • Preparation phase

  • 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

  • Follow-up

  • 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

Process development-related

  • 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)

Qualifications

Specific professional/technical requirements:

Education: MSc/BSc or equivalent

Languages: English

Specific Knowledge:

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.

Experience:

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.

Other:

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.

Primary Location

Netherlands-South Holland-Leiden

Organization

Janssen Vaccines & Prevention BV (8852)

Job Function

Product Development

Requisition ID

1700196826W