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!
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