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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.
- 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.
- 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
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.