Principal Scientist (m/f/d)
- Minimum: Completed degree with ideally a PhD in biotechnology, chemistry or other natural sciences and at least 2 years of relevant experience in the biopharmaceutical industry, or a Master of Science with 6 years of relevant experience.
- Excellent knowledge in the field of analytical characterization of biopharmaceutical products, laboratory and technical expertise (analysis of proteins / antibodies, data evaluation). Theoretical and scientific knowledge in other areas (e.g. manufacturing, pharmaceuticals).
- Comprehensive understanding of development activities and processes in the biopharmaceutical field, good knowledge of the relevant regulatory guidelines, as well as understanding of regulatory expectations.
- Extensive experience in preparing analytical reports and regulatory dossiers in English and excellent presentation skills
- Strong background in the requirements and activities related to the analytical characterization of biopharmaceutical projects. Desirable: Late-stage project experience / interaction with regulatory authorities / proven contribution to relevant document submissions
- Business fluent language skills in English
- Independent management and administration of all project activities in the field of analytical characterization and contribution to project-related, strategic decisions and financial planning within the project responsibility
- Lead assigned functional analytical sub-teams; Representation in technical teams (e.g. global CMC team); Fulfillment of all project tasks and responsibilities in relation to own area of responsibility, as well as, support of the management team in setting goals and performance evaluations of team members.
- Independent interpretation and presentation of results, data evaluation and drawing up the relevant conclusions; Carrying out complex tasks without having established procedures. Review and approval of raw data generated by others.
- Development, optimization, validation, application and transfer of analysis methods, as well as the monitoring of all scientific and technical characterization activities of the assigned projects
- Creation of protocols, scientific reports, laboratory procedures or process-related SOPs; Writing of scientific documents for external partners (e.g. other line units, authorities). In particular: Creation of individual chapters of approval documents and, if necessary, direct interaction with authorities.