Expected Annual Base Salary Range for role: 126,000.00 - 234,000.00 CHF
Endet in 30 Tagen
Anforderungen
8+ J. Erfahrung
Doktortitel
Skills
Resource planningTechnical expertise in auditsMethod transferMethod validationMolecule characterizationBudget managementCommunication SkillsRegulatory submissionsGxP complianceComponent specificationBiopharmaceutical characterizationAnalytical method development
Sprachen
Englisch C2
Vergütung
Expected Annual Base Salary Range for role: 126,000.00 - 234,000.00 CHF
Beschreibung
Your Key Responsibilities:
You are responsible for the overall analytical project strategy including robust and phase-dependent control strategy to support technical development of highly innovative biologic products.
You will lead and coordinate the analytical sub-team in a matrix organization and represent the analytic discipline in the global CMC project team of assigned projects.
You are accountable for managing all analytic related activities of drug product and drug substance development including release and stability testing, molecule characterization, method- development, -transfer and -validation, specification setting, know-how transfer etc.
You will lead and coordinate timely delivery of high quality source documents for submission, review of regulatory documents and interact with Heath Authorities in audits and scientific advice meetings.
You will need to communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc.
You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level.
You are responsible for high quality analytical registration documents for HA submissions and interact with authorities, act as technical expert in audits, inspections etc.
You are responsible for analytical budget and resource planning.
Aufgaben
You are responsible for the overall analytical project strategy including robust and phase-dependent control strategy to support technical development of highly innovative biologic products.
You will lead and coordinate the analytical sub-team in a matrix organization and represent the analytic discipline in the global CMC project team of assigned projects.
You are accountable for managing all analytic related activities of drug product and drug substance development including release and stability testing, molecule characterization, method- development, -transfer and -validation, specification setting, know-how transfer etc.
You will lead and coordinate timely delivery of high quality source documents for submission, review of regulatory documents and interact with Heath Authorities in audits and scientific advice meetings.
You will need to communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc.
You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level.
You are responsible for high quality analytical registration documents for HA submissions and interact with authorities, act as technical expert in audits, inspections etc.
You are responsible for analytical budget and resource planning.
Anforderungen
PhD and minimum of 8 years relevant experience of Biologics CMC development or University life-science degree with appropriate industry experience.
Excellent theoretical and profound scientific knowledge in analytical areas in biologic drug development.
Strong scientific leadership, bringing innovative molecules from research to development.
Excellent understanding of regulatory expectations and requirements with significant experience with IND/ BLA submission.
Strong experience in leading matrix teams and strong communication skills.
Technologien
Budget ManagementCoaching SkillsData ScienceExperiments DesignLaboratoryProblem Solving SkillsProcess SimulationR&DWaterfall Model
Vorteile
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives.
We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
