(senior) Manufacturing Fill & Finish Process Specialist | Biopharmaceuticals | Zuid-Holland
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 and Biotechnology organisation, based in Zuid-Holland Netherlands.
o review of the (master and executed) batch documentation prepared by the manufacturing site and bringing it to the required quality level;
o being physically present during drug product manufacturing (Person in Plant, PiP), resolving issues on the spot and guiding corrective measures if required;
• Establishing and maintaining a trustful and professional relationship with the external drug product manufacturing sites;
• Participating in the multidisciplinary project teams, ensuring alignment with project needs;
• Identifying and implementing improvements in the way of working;
• Being all-round expert in quality, regulatory, technical and business aspects of external manufacturing.
- At least 5 years of experience (10 years for senior position) in vaccine and/or large molecule GMP drug product manufacturing.
- Experience with process development, project management and outsourcing is an advantage.
- pro-active, flexible and full of initiative.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
The Company
They are one of the biggest and most respected health care companies in the world. This company is dedicated to the development of novel therapeutics and vaccines to treat, cure and prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern such as polio and Ebola.Role Description
The Fill & Finish Process team is responsible for the external manufacturing of drug product. As Manufacturing Fill & Finish Process Specialist you operate at the technical interface between the project teams and the external drug product manufacturing sites.Responsibilities
• Proper and timely execution of drug product manufacturing activities;o review of the (master and executed) batch documentation prepared by the manufacturing site and bringing it to the required quality level;
o being physically present during drug product manufacturing (Person in Plant, PiP), resolving issues on the spot and guiding corrective measures if required;
• Establishing and maintaining a trustful and professional relationship with the external drug product manufacturing sites;
• Participating in the multidisciplinary project teams, ensuring alignment with project needs;
• Identifying and implementing improvements in the way of working;
• Being all-round expert in quality, regulatory, technical and business aspects of external manufacturing.
Requirements
- MSc/BSc in pharmaceutical sciences or other relevant disciplines (i.e., pharmacy, (bio)chemistry)- At least 5 years of experience (10 years for senior position) in vaccine and/or large molecule GMP drug product manufacturing.
- Experience with process development, project management and outsourcing is an advantage.
- pro-active, flexible and full of initiative.
Other information
Submit your application before the 27th of November.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
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