Senior Fill Finish Specialist

Bedrijfsnaam: -
Plaatsingsdatum: 27/09/2018
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 Pharmaceutical organisation, based in Zuid-Holland Netherlands.The CompanyOur client is a professional Pharmaceutical organisation, based in Netherlands. In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. We are continuously looking for enthusiastic, talented people who have the ambition to develop themselves.

Role DescriptionThe Fill Finish Specialist 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.

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

- Preparation phase
o Contribute as required to CMO selection process (accountability/responsibility at Head of Production)
o Responsible as technical SME for alignment with QA
o Responsible for technical input for QAA, MSA and related SOWs
o Responsible for the process description and Process-Fit-2-Plant activities, including confirmation and technology transfer runs
o 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 QA system
o Responsible for assessing the technical readiness of the external partner prior to starting manufacturing (accountability Head of Production)

- Technical oversight manufacturing
o 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.
o 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 our organisation 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- Good communication skills in English, Dutch and German is a plus
- 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 years of 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.
- Broad experience in applicable quality, regulatory, technical and business aspects.
- independent on location, flexible, collaborative, communicative and motivating, enjoys working in a team.

Other information- Location: You need to be able to travel frequently (25%) and stay abroad for up to 2 weeks.

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




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
5 - 10 jaar
Contactgegevens :