Senior Specialist Downstream Process Development

Polpharma Biologics is already finalizing its new R&D and manufacturing facility in Duchnice, Poland. In this new facility we are currently establishing Research & Development department to develop, optimize and characterize protein production processes from the laboratory phase to the large scale. For our R&D Department we are currently looking for a Senior Specialist in Downstream Process Development.
In this position you will join a team of scientists focused on the development and characterization of downstream processes in R&D department.
 
 

•     Planning and conducting lab studies for development, optimization and characterization of production purification 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 as economic aspects
•     Evaluation of external suppliers of resins, filter membranes, disposable materials etc. 
•     Supporting GMP manufacturing during scale-up, technology transfer and through process investigations, deviations and change control assessments 
•     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
•     Extensive experience in protein purification processes and techniques 
•     Excellence in handling of lab scale chromatography systems, filtration units tangential flow filtration (TFF) equipment, 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

•     Competitive salary
  •     Private healthcare
  •     Life insurance
  •     Pension plan above national standards
  •     Relocation package
  •     Additional free day
  •     and more..