Upstream Process Development Senior Specialist

In this position you will join a team of scientists focused on the development and characterization of upstream processes in R&D department.

• Planning and conducting lab scale studies for development, optimization and characterization of production upstream processes, including establishment and qualification of SDM, process characterization, small scale validation supportive studies
• Supporting all activities related to setting up process development lab with GLP and organizational & safety standards
• Writing URSes and participating in equipment qualification
• Participating in project planning, including timelines and resources for internal and CDMO projects
• Providing training and support to junior team members
• Accurate and complete documentation of scientific observations, data analysis, planning next experimental steps, reporting results and conclusions during group, project and other meetings
• Supporting team members in preparation of documents like SOPs, protocols and reports, process description, risk assessments etc.
• Providing technical and scientific coverage for lab-scale and production operations – you may be a lead in reference to diverse aspects of process development and transfer activities
• Seeking and identifying improvements and optimization of the process with regards of technical as well economic aspects
• Evaluation of external suppliers of media, filters, disposable materials etc.
• Supporting GMP manufacturing during scale-up, technology transfer and through process investigations, deviations and change control assessments
• Collaboration with DSP, Analytical, TechOps, PM, QA/QC, Regulatory, IP and external CDMO clients in order to achieve optimal results

• University degree in Biotechnology or related field (PhD is a plus)
• At least 3 years of experience in upstream process development in biotech or pharmaceutical industry
• Extensive experience in USP processes and techniques within a mammalian cell culture (ideally CHO)
• Excellence in handling of various bioreactor systems and scales (ambr™ systems, 1-10L stirred-tank bioreactor, 10L is desired), single use bioreactor (50L is desired), wave bioreactor, cell harvesting, filtration, centrifugation, etc.
• Experience in writing SOPs, complex protocols and technical reports
• Experience in applying DoE methodology
• Experience in playing a leading role in project activities and supporting junior team members
• Experience in supporting GMP manufacturing, process scale-up and transfer to/from external clients is a plus
• Understanding of analytical methods to monitor processes
• Proven ability to work effectively within group and within cross-functional project teams
• High level of initiative, independence, as well as excellent organizational skills
• Excellent English