Upstream Process Development Team Coordinator

In this position you will be leading the team of scientists and coordinate the development and characterization of upstream processes in R&D department.

• Recruitment and development of assigned team to be capable of championing technical aspects of upstream process development
• Planning and execution of 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
• Coordination and directing of actions of the team to achieve team and project goals
• Reporting work progress during group, project and other meetings
• Reviewing and approving process and project documentation as well as SOPs applying to the USP lab
• Providing technical and scientific coverage for lab-scale and production operations
• Assessing improvement and optimization of the process with regards to technical as well as economic aspects
• Evaluation of external suppliers of media, filters, disposable materials etc. and maintaining knowledge and understanding of new technologies in the field
• Supporting GMP manufacturing during scale-up, technology transfer and through process investigations, deviations and change control assessments
• Ensuring the team, equipment and records/data are compliant with pharmaceutical regulations
• Collaboration with CLD, 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 USP development in biotech or pharmaceutical industry, including development, optimization and characterization of processes 
• At least 1-2 years as a leader/coordinator of scientific or development team with proven ability of successful management of the group and project activities
• Expertise in USP processes and techniques within a mammalian cell culture (ideally CHO) with in-depth understanding of biological and engineering factors affecting performance and quality attributes
• Hands-on experience in handling: various bioreactor systems and scales (ambr™ systems, 1-10L stirred-tank bioreactor, 10L preferably), single use bioreactor (50L is desired), wave bioreactor, cell harvesting, filtration, centrifugation, etc.
• Working knowledge of DoE methodology
• Knowledge of production scale processes and equipment
• Understanding of DSP process and analytical methods used to monitor the processes
• Experience in process scale-up and transfer to/from external clients is a plus
• Excellent communication, organizational and project management skills, ability to think creatively with a proven ability to solve problems