Associate Scientist/ Senior Manufacturing Operator
Company: International Biopharmaceutical
Location: Leiden Area
Starting date: February (preferred)
Would you like to be directly involved in the fight against the global "Corona virus" (COVID-19) pandemic? Then keep reading!
Currently we are actively recruiting a Associate Scientist for a multinational Biotech company that has been for over 25 years a leader in the field of biomedicine. Our client is a biotech company that focuses on the development, production and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.
Their talented, entrepreneurial people are working in a dynamic culture in which innovation and a ‘can do’ state of mind are the central points. In order to strengthen their team, they are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value for their organization.
The Associate Scientist will join The Drug Substance Operations (DSO) department that has a GMP manufacturing facility at the Bioscience Park in Leiden where groundbreaking medicines are produced against diseases that have a global impact, such as vaccines against HIV, RSV and Ebola. This is also the place where we will be producing the COVID-19 vaccine material.
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. Our passion is to deliver high-quality results to our customers and to seek for opportunities for improvement: never a dull moment!
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.
• has quality always as main goal, efficiency second
• aims for full customer satisfaction. What is asked you deliver with the required quality within the agreed timeframe.
• has a high degree of accuracy, initiative, and independence
• is flexible and stress-resistant and remains positive when priorities change
• helps team members by giving advice and sharing feedback on technical and personal level
• has great social and trainer skills, is able to provide and receive feedback in a constructive way. You make yourself part of discussions and help transform these into positive actions.
• 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
If you are interested in this position, please apply or email email@example.com