Organization Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, Singapore, and the EU.
Department Description
As MSAT Scientist you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the MSAT Team Lead. This role is being offered as a 12month Maternity Fixed Term Contract.
- GMP Commercial/Clinical manufacturing experience in a mammalian Cell culture/purification setting (perfusion or fedbatch) operations and associated requirements.
- Act as an SME for Upstream/Downstream, including technology transfer, process validation, trouble shooting and investigation.
- Author or review and approve process validation strategies, protocols and reports.
- Performs tasks for execution of simple lab studies/analytical work with a high level of autonomy, and more complex studies/analytical work with supervisory input and in accordance with study protocols or SOPs.
- Drafts study protocols and reports independently with supervisor/ peer review.
- Performs intermediate level of statistical data analysis with the ability to recognize trends and areas where more analysis should be performed. Performs basic statistical data analysis, charting, linear regression analysis.
- During the start-up phase of the facility this position will also provide support in building the MSAT function in Dundalk, including documentation generation and qualification of the MSAT laboratory equipment.
- Lead risk assessments in support of new product initiation for transferring new products and processes.
- Support Health Authority audits.
- Support and lead scientific investigations ensuring that the true root cause and effective CAPA are identified and implemented.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
- Will be flexible to take on additional tasks and responsibilities at the discretion of their manager.
- Will act as a role model for the MSAT function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
- Doctorate in a biotechnology area ideally or science related discipline is preferable.
- Minimum of Bachelor of Science degree in biotechnology area ideally or science related discipline.
- Minimum of 2 years’ Upstream and or Downstream experience in a large-scale Biopharmaceutical facility however position will be commensurate with experience.
- Thorough knowledge of Upstream and or Downstream Processes and current Good Manufacturing Practices (cGMP).
- Previous experience in new product technology transfers into a clinical/commercial facility.
- Experience of authoring process validation protocols and reports.
- Working laboratory experience within upstream and downstream is ideal however, experience in either functional area will be considered.
- Upstream: Hands-on experience in aseptic Techniques, running of bioreactor (mammalian or microbial cells) is ideal.
- Downstream process: Hands-on experience in downstream unit operations such as chromatography, ultrafiltration/diafiltration, virus filtration etc.
- Analytical: Working knowledge of general protein characterization assays, e.g. gel based, chromatographic, and immuno-affinity-based assays is ideal.
- Working experience with protocol, report writing and data analysis is required.
- Technical experience working technology transfer and process validation activities.
- Excellent focus and attention to detail.
- Problem solving capabilities.
- Ability to work independently and as part of a cross functional collaborative team to achieve mutual goals.
- Good presentation skills, teamwork and ability to interact effectively with internal and external project teams, including customer communications.
- Excellent communication skills.
- Excellent cross functional collaboration working
- Must be willing to travel as required internationally to fulfil the responsibilities of the position
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now!