Analytical Bio Project Principal Scientist
Who we are looking for
Purpose
Accountable for analytical development, validation and transfer of methods as well as characterization of biotechnology derived products.
Collaborate closely with internal experts and external CDMO partners.
Tasks will range from early-phase method development to late-stage analytical support of product approaching market approval.
Main Responsibilities
- Responsible for development and validation of analytical methods mostly in collaboration with CDMO
- Responsible for the biological characterization of the recombinant proteins in collaboration with relevant CRO’s
- Write protocols, reports, SOPs and technical documentation
- Provide expert analytical support in cross-functional projects and work streams
- Ensure all work is performed in accordance with industry standards, guidelines and regulatory requirements
- Ensure appropriate reporting and documentation of activities and project progression. Provide technical and science-based solutions to projects.
- Supporting regulatory documentation and contributing to quality assurance
Experience Required
- At least 5 years’ experience from the biotechnology industry
- Extensive expertise within protein analysis and characterization
- Experience of development, validation and transfer of analytical methods
- Experience of Bioassay method development and validation is valuable
Experience from regulatory controlled work / processes
Broad general experience in adjacent fields for the development of biopharmaceuticals
Education
Degree in Analytical Chemistry, Biotechnology or similar
Languages
Strong written and spoken English
Soft Skills
- Analytical skills
- Planning and organizational skills
- Problem solving
- Quality orientation
- Team working
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.