Fill Finish Specialist - Manufacturing - Pharmaceuticals

FILL FINISH SPECIALIST - LEIDEN, NETHERLANDS - UP TO 50 EUR (PER HOUR)/11 MONTHS

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

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

o Responsible for evaluating process performance and costs, providing input for CMO oversight metrics and process development, and sharing best practices with peers

o 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

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

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)

EDUCATION:

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

Languages: English (required), Dutch (plus), German (plus)

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 in vaccine and/or large molecule process development and/or manufacturing.

Is able to travel frequently (25%) 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.

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