Fill Finish Specialist

Bedrijfsnaam: -
Plaatsingsdatum: 14/09/2018
Standplaats: -


SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Biotechnology organisation, based in Noord-Holland Netherlands.The CompanyThis Multinational is specialized in biotechnology vaccines and biopharmaceutical technologies.

Role DescriptionThe 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. The contract is for 12 months and there is a possibility that the contract could be extended by the employer.

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
- 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 the company 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

Requirements- MSc/BSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering.
- At least 5 years of experience in vaccine and/or large molecule process development and/or manufacturing.
- Experience with process development, technology transfers, GMP manufacturing, outsourcing, troubleshooting, conducting audits and due diligence visits.
- 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.
- English (required), Dutch (plus), German (plus)

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Asanka Boxma.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
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