Oferta pracy

Upstream Process Development Senior Specialist

Polpharma Biologics S.A.O firmie

Polpharma Biologics S.A.

Spółdzielcza 4

Duchnice (pow. warszawski zachodni)

#PolpharmaBiologics 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!
Upstream Process Development Senior Specialist
Duchnice (pow. warszawski zachodni)

WHAT MAKES US SPECIAL

  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world 

 

In this position you will join a team of scientists focused on the development and characterization of upstream processes in R&D department.

 

You will take care of:

  • 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 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 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:

  • University degree 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

We offer:

  • Sport card
  • Development programs
  • Private healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • and more
 

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