Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Fill/Finish Process Manufacturing Specialist

Eingestellt von Elevate Direct

Gesuchte Skills: Engineering, Design

Projektbeschreibung

Fill/Finish Process Manufacturing Specialist - Leiden, Netherlands

The individual operates at the technical interface between Janssen Vaccines & Prevention Leiden (JVL) and the (external) DP manufacturing sites. The main purpose of the individual is to ensure proper and timely execution of outsourced DP manufacturing activities in compliance with applicable quality standards, as required for supply of clinical trials. The related responsibilities range from the selection of the Contract Manufacturing Organization (CMO) in the preparation phase until supporting the QP for the batch disposition.

Key responsibilities:

Accountable for proper and timely execution of outsourced manufacturing activities as defined in programs plans.

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 subject matter expert for alignment with QA

Responsible for the implementation of the manufacturing process

Responsible for review of the documentation prepared by the external partner that is required for manufacturing, and bringing it to the required quality level

Responsible for assessing the technical readiness of the external partner prior to starting manufacturing (accountability Head of Production)

Technical oversight manufacturing, when required acting as person in plant at the DP manufacturing site resolving issues on the spot and guiding corrective measures if required.

Responsible for timely informing/escalating issues to Head of DP manufacturing and Technical Integrator as needed

Responsible for ensuring timely closure of DP manufacturing related deviations, changes and CAPAs, ensuring aligned expectations between JVL and the external partner

Responsible to generate the required documentation and provide required support to enable timely and successful batch disposition by the QP 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

Communication skills, including conflict prevention/handling

Adherence to TI model (communication, escalation, project alignment)

Qualifications Specific

MSc/BSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering.

Languages: English and Dutch

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 quality and regulatory guidelines. Experience:

Experience in vaccine and/or large molecule GMP drug product manufacturing.

Broad experience in applicable quality and regulatory guidelines, aseptic GMP manufacturing, outsourcing and troubleshooting

Flexible, collaborative, communicative and motivating, enjoys working in a team.

Able to travel frequently (20%) and stay abroad for up to 2 weeks.

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly

Projektdetails

  • Einsatzort:

    Leiden, Niederlande

  • Projektbeginn:

    asap

  • Projektdauer:

    11 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Elevate Direct