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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..
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Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.