Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
Head MS&T
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
Currently we’re looking for
1
Head MS&T
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Establish and maintain MS&T organizational capability and governance processes to
- Lead validation and ensure execution of Validation Master Plans and continuous data monitoring/trending
- Keep technology strategies to current and future standards in partnership with key functions (Production, Development, QA/Regulatory, Business)
- Execute product remediation of technical issues and provide technical support
- Product Stewardship: full accountability and oversight of product related technical process and quality aspects to ensure manufacturing of robust products (Lifecycle Management of a production process)
- Technical Stewardship: Oversight and definition of processes and standards to maintain existing technologies and implement new innovative technologies for manufacturing including the development of requirements for new equipment vTechnical Transfer Leadership: Lead technical transfers of products within and between sites as well as from development into large scale facilities
- 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.
- Validation Leadership: Own and write VMP. Provide governance for site validation activities. Perform scientific evaluation/risk assessments of APR/PQR, CPP/CQA, CPV
What do we expect?
- 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
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.