#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 medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
In our Technical Operations department we are now looking for an experienced person to lead our MS&T team. This is an essential role which will focus on maintaining and improving the scientific oversight of the manufacturing processes and technical changes and ensuring the products stewardship across process units and functions.
- Validation Leadership: ownership and execution of Validation Master Plans. Managing site
validation activities. Performing scientific evaluation/risk assessments of APR/PQR, CPP/CQA,
CPV - Product Stewardship: Ensuring robust product stewardship and end-to-end technical oversight of product manufacturing processes, at all stages of their lifecycle.
- Process Support Leadership: Ensure end-to-end oversight of process performance and early initiation of corrective actions based on monitoring of product/process parameters. Ensure current process technical issues are solved in a timely manner, drive implementation of CAPAs etc.
- Technical Stewardship: Oversight and definition of processes and standards to maintain existing technologies and implement new innovative technologies for manufacturing
- Technical Transfer Leadership: Lead technical transfers of products within and between sites as well as from development into large scale facilities
- Documentation management: Preparation of Validation Documentation: including procedures, forms, protocols; review of product/process documentation: batch records, production protocols, manufacturing formulae
- Working collaboratively with key functions (Production, R&D, QA/Regulatory, Business) to ensure the projects are identified, prioritized and delivered with excellence and keeping the technology strategies to current and future standards.
- 5-8 years of experience in manufacturing/manufacturing science or technology/technical development
- Thorough understanding of manufacturing processes (Up- & Downstream) and related process equipment
- 2-5 years of experience in executing process validation, having led and managed validation projects
- Expert in reviewing and writing technical reports
- Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
- Strong in leadership and people management, with ability to build up and develop the team
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
- Fluent in English, willing to learn Polish language
- Flexible and adaptable
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com