#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
- Responsible for establishing and coordinating the data management operational activities in order to achieve high quality databases, in a timely manner, to support processes from drug substance and drug product development up to manufacturing as well as supporting strategic vendor relationships.
- As a member of the Manufacturing Science and Technology Department Team, coordinate and manage opportunities for process optimization, interfaces with other departments and functions and coordinate user requirements for SDM technologies
- Contributes to implementing ongoing improvements within Data Management to ensure data integrity and data quality requirements of process development and manufacturing
- Develop, review and implement Data Management processes, policies and SOPs
- Develop Data Management metrics and key performance indicators
- Identifies opportunities and implements solutions to globalize and standardize methods, processes, procedures, systems and templates in accordance with regulatory authorities requirements and industry best practices
- Oversees planning, execution and maintenance of major projects, if required.
- Support study-level/program audit and inspection readiness activities as needed.
- Lead data management support of submission activities.
- Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences.
- Ensure the delivery of quality data by partnering with other departments across Polpharma Biologics Group members and external clients
- Train and mentor the identified representatives in the different departments and functions to carry out and sustain SDM, projects, systems and programs.
- Perform hands-on data management responsibilities
- MSc degree, a scientific or engineering discipline.
- 5+ years working with data management tools, with experience building data management functions and developing initiatives designed to promote efficiency and productivity.
- Advanced hands-on knowledge of data management processes and systems/software.
- Experienced in biopharma industry will be valued and knowledge of regulatory requirements (e.g. ICH, EMA, FDA)
- Strong project management skills, and ability to effectively lead and collaborate with various business functions
- Ability of working on multiple projects simultaneously, independently managing competing priorities, and define tracking tools to manage projects
- Excellent written and verbal communication skills, able to communicate effectively with senior management as well as with peers.
- Understanding of biological drug development and manufacturing processes
- Experience with data visualization, analytics and reporting tools
- Fluent English
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
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Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.