Analytical Bio Project Principal Scientist
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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
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Research
Industries
Pharmaceutical Manufacturing
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