Downstream Process Development Team Coordinator

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

• Recruitment and development of assigned team to be capable of championing technical aspects of downstream process development
• Planning and execution of lab studies for development, optimization and characterization of production purification processes, including establishment and qualification of SDM, process characterization, small scale validation supportive studies
• Coordinating and directing actions of the team to achieve team and project goals
• Reporting work progress during group, project and other meetings
• Review and approve process and project documentation as well as SOPs applying to the Downstream lab
• Providing technical and science coverage for lab-scale and production operations
• Assessing improvement and optimization of the process with regards of technical as well as economical aspects
• Evaluation of external suppliers of resins, filter membranes, 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 USP, 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 downstream process development in biotech or pharmaceutical industry
• At least 1-2 years as a leader/coordinator of scientific or development team with proven ability of successful management of group and project activities
• Expertise in protein purification processes and techniques
• Hands-on expertise in handling of lab scale chromatography systems, filtration units, tangential flow filtration (TFF) equipment, etc.
• Experience with DoE methodology
• Knowledge of production scale processes and equipment
• Understanding of USP process and analytical methods to monitor the processes
• Experience in process scale-up and transfer to/from external clients is a plus
• Excellent communication, organizational and project coordination skills, ability to think creatively with a proven ability to solve problems