USP Process Development Senior Specialist (Perfusion)

Your Role
 
Polpharma Biologics is already finalizing its new R&D and manufacturing facility in Duchnice, Poland. In this new state-of-the 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 Process Development (Upstream).
 
As Senior Specialist in Process Development (Upstream) you will be in a team of scientists focused on the development and characterization of upstream processes in R&D department.
 
Your Responsibilities

• Planning and conducting lab scale studies for process development, optimization of a perfusion 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 good laboratory practices 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 science coverage for lab-scale and production operations – may lead 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.

If You Have

• Higher education in Biotechnology or related field (PhD is a plus)
• At least 3 years of experience in upstream process development, especially in perfusion process in biotech or pharmaceutical industry
• Extensive experience in USP perfusion processes and techniques including handing of ATF system (ATF2, ATF6 and ATF 10)
• 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 in writing and speaking

We offer:

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