Senior Fill Finish Specialist
Location: NetherlandsSIRE® 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 Netherlands.
Furthermore, you are 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.
• Establishing and maintaining a trustful and professional relationship with the external partner
• Participate in DPD sub team, ensuring alignment with project needs through Technical Integrator
• Responsible as technical SME for alignment with QA
• Technical input for QAA, MSA and related SOWs
• The process description activities, including confirmation and technology transfer runs
• Reviewing 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
• Assessing the technical readiness of the external partner prior to starting manufacturing (accountability Head of Production)
• 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.
• Evaluating process performance and costs, providing input for CMO oversight metrics and process development, and sharing best practices with
peers
• Closing deviations and CAPAs, ensuring aligned expectations between Crucell and the external partner Process development-related
• At least 5 years of experience in vaccine and/or large molecule process development and/or manufacturing.
• English (required), Dutch (plus), German (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.
• Experience with the following is a strong advantage: process development, technology transfers, GMP manufacturing, outsourcing, troubleshooting,
conducting audits and due diligence visits.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Femke Sneek.
The Company
A global biotech organization that focuses on the development, production and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases. They are always looking for a talented, entrepreneurial person that would like to work in a dynamic culture in which innovation and a ‘can do’ state of mind are the central points.Role Description
You will be operating at the technical interface with external partners. Your 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, you are accountable and responsible for Process-Fit-2-Plant activities (in case of external partners), including confirmation and technology transfer runs.Furthermore, you are 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
• Proper and timely execution of outsourced manufacturing activities as defined in SOWs• Establishing and maintaining a trustful and professional relationship with the external partner
• Participate in DPD sub team, ensuring alignment with project needs through Technical Integrator
• Responsible as technical SME for alignment with QA
• Technical input for QAA, MSA and related SOWs
• The process description activities, including confirmation and technology transfer runs
• Reviewing 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
• Assessing the technical readiness of the external partner prior to starting manufacturing (accountability Head of Production)
• 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.
• Evaluating process performance and costs, providing input for CMO oversight metrics and process development, and sharing best practices with
peers
• Closing deviations and CAPAs, ensuring aligned expectations between Crucell and the external partner Process development-related
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.
• English (required), Dutch (plus), German (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.
• Experience with the following is a strong advantage: process development, technology transfers, GMP manufacturing, outsourcing, troubleshooting,
conducting audits and due diligence visits.
Other information
You will have to work independent on location. In addition, you are a flexible, collaborative, communicative and motivating person who enjoys working in a team. This job requires you 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 Femke Sneek.
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