For our client, a company in pharmaceuticals, we are looking for a Senior Operator Drug Substance based in Leiden.
The department DSO is an international team of about 40 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA and warehouse.
To strengthen the department we are looking for an Associate scientist / Senior manufacturing operator, to help us realize the upcoming COVID-19 vaccine manufacturing campaign.
Within the department four teams operate, each with specific responsibilities: Preparations, Cell culture, Downstream processing and the Operations Support Team. The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues and performing the resulting corrective actions, master batch documentation, training and inspection readiness.
The associate scientist is primarily responsible for the cGMP production of CTM material, as requested by the organisation. Apart from production operations you will be updating documentation, be responsible for predefined process steps, and the state of related equipment. Next to these core tasks small improvements and innovative projects will be a stable part of your daily work package. You will also be tasked to do data management, acute problem solving, and many other small and diverse tasks. As the job entails team work within a diverse and global organisation, we require good communications skills in English.
- HBO/BSc with 3 years of proven experience in pharmaceutical/biotechnology;
- Expert in cell culture (USP), virus propagation and / or downstream processing (DSP);
- Experience with change controls, non-conformances and CAPA records;
- Experience with cGMP and EHSS standards is required;
- Lean green belt certification is preferred
- You have quality always as main goal, efficiency second;
- You aim for full customer satisfaction.
- You have a high degree of accuracy, initiative, and independence;
- You are flexible and stress-resistant and remain positive when priorities change;
- You help team members by giving advice and sharing feedback on technical and personal level;
- You have great social and trainer skills, are able to provide and receive feedback in a constructive way.
What do we offer
- Contract via Kelly Services of 2 years (40 hours per week)
- Start date: asap
- An international environment where you can learn a lot in challenging projects
When interested please react through the application process with your English resume.
About Kelly Services
It's more than a job. It's passion.
Our vision is to provide the world's best workforce solutions. We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.
At our core, we are a community. Each day we welcome into our community the varied talents of all people who embrace our culture of service, teamwork and integrity. We offer the opportunity to work with the best companies in the world, and to make a difference in the communities in which we live and work.
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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.