Operator CNC

Senior Specialist Downstream Process Development

Duchnice

Boost your career with us

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!

Role:

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

Your responsibilities:

Planning and conducting lab studies for development, optimization and characterization of production purification 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 as economic aspects
Evaluation of external suppliers of resins, filter membranes, disposable materials etc.
Supporting GMP manufacturing during scale-up, technology transfer and through process investigations, deviations and change control assessments
Collaboration with USP, 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 downstream process development in biotech or pharmaceutical industry
Extensive experience in protein purification processes and techniques
Excellence in handling of lab scale chromatography systems, filtration units tangential flow filtration (TFF) equipment, 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

Why you should work with us