Challenging opportunity to deliver assigned project deliverables in full as planned pre-clinical and clinical batches
Over de functie
Yacht Life Sciences has a vacancy for a Fill Finish Specialist.
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.
- 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:
- 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 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 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
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: 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. For senior function: broad experience in applicable quality, regulatory, technical and business aspects.
Other: Independent on location, flexible, collaborative, communicative and motivating, enjoys working in a team. Is able to travel frequently (25%) and stay abroad for up to 2 weeks. Interpersonal skills and business acumen are key for this position.
Secondment placement for 1 year with longer-term possibilities. Full-time position, 32 hours can be discussed,
We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
A global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
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