A speciality biopharmaceutical company is currently recruiting a USP Development Team Lead to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.
The Upstream Process Development team are responsible for the end-to-end development of processes from the early use process development right through to technical transfers to manufacturing. This department works in teams of scientists and develop from 2L scale up to 10L scale carrying out screening experiments to characterize the process from shake flask to production bioreactor and then to harvest.
As a level 3 scientist in upstream process development, you will be fulfilling a senior role in a team of scientist that is responsible for the development of bioreactor processes and subsequent scale-up and transfer to a manufacturing environment. Your activities will consist of lab support tasks, including, but not limited to, solution/media preparation, bioreactor assembly and performing bioreactor experiments.
Furthermore, you will be responsible for execution (or overseeing) of experiments in all USP unit operations (SF, Ambr, rocker, bioreactors and harvest), including data collection, analysis and reporting.
Job Responsibilities:
- Execute / oversee experiments in an accurate way, ensure data capture is accurate and complete
- Ensure accurate and complete documentation of lab activities, write appropriate technical development plans and reports.
- Evaluate cell culture performance, process in- and outputs and product quality attributes in labscale bioreactors.
- Optimize bioreactor conditions regarding cell culture performance, process controls and product quality attributes.
- Ensure accurate and complete documentation of lab activities, write appropriate technical development plans and reports.
- Write plans, reports for screening studies and process characterization studies for all USP unit operations.
- Author, amend and review operating documents, such as SOPs and batch records
- Contributes to ensure the USP development suite and equipment is maintained in an orderly fashion.
- As a SME (subject matter expert), contribute to successful commercial Pre-Approval Inspections, regular audits and others as required.
- Write/review/approve appropriate written procedures, technical documents, reports and other cGMP documentations.
- Provide technical, scientific leadership and guidance to the USP development team to ensure efficient development and characterization of an upstream process.
- Contribute to successful commercial Pre-Approval Inspections, regular Audits and any other interactions with regulatory agencies as required.
- Maintaining leading-edge knowledge and understanding of new technologies in the field of USP process development and proactively share knowledge with the team.
- Willing to participate in a rotation schedule for weekend work.
Skills and Requirements:
- Degree in life science, biotechnology or related subject.
- Minimum of 5 years' experience in biopharmaceuticals or technical field desired.
- Knowledge of upstream development activities (lab scale (=must) and production scale) including hands-on expertise operating upstream equipment.
- Experience with fed-batch and perfusion mode.
- Experience with screening experiments (Ambr or comparable).
- Experience applying QbD (quality by design) and DoE approach to develop and trouble shoot development activities.
- Experience in harvesting techniques.
- Experience in process characterization, process validation.
- Understanding of scale up/scale down.
- Understanding of statistical methods and implementation.
- Experience with statistical program.
- Demonstrable experience in a similar or relevant role.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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