USP Process Development Senior Specialist (Fed-batch culture)
Duchnice
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Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
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 development, optimization and characterization of production upstream 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 in biotech or pharmaceutical industry.
- Extensive experience in USP processes and techniques within a mammalian cell culture (ideally CHO).
- 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.