Key responsibilities

Development, optimization and upscaling of GMP-compatible manufacturing processes for lyophilization of biologics (eg Anti-body drug conjugates, ADCs), including preparation and documentation of development activities
Creation of risk analyzes and statistical design of experiments (DoE) within the framework of formulation and process development of biologics
Co-working with a young development team for developing and extending the department analytical capabilities with focus on physicochemical characterization of Biologics, as well as the occupational health and safety concepts for handling of high potent compounds
Functional and technical management of contract manufacturing organizations (CMOs) for clinical trials material manufacturing, as well as technology transfers to in-house manufacturing sites and CMOs in Europe, including on-site support
Supporting the team in creating and reviewing manufacturing protocols and reports
Support the preparation of regulatory submission documents; including NDA, and BLA.
Collaboration with various international multidisciplinary project teams (including colleagues from Japan, US and CMOs in Europe)

Personal skills and professional experience

University degree in Pharmacy or related subject, ideally with PhD in Pharmaceutical Technology (focus on Lyophilization and Biologics)
At least two years of relevant work experience in pharmaceutical industry (formulation and process development).
Previous experiences with CMO management, global CMC development, technology transfer and handling of high potent biologics are preferable.
Experience in Design of Experiments and upscaling of GMP-compatible manufacturing processes (Fill and Finish)
Previous expertise in CMC regulatory requirements and submissions
Very good written and oral communication skills in English and German
Very good IT skills (MS Office, SAP etc.)

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Responsibilities

Development, optimization and upscaling of GMP-compatible manufacturing processes for lyophilization of biologics (eg Anti-body drug conjugates, ADCs), including preparation and documentation of development activities
Creation of risk analyzes and statistical design of experiments (DoE) within the framework of formulation and process development of biologics
Co-working with a young development team for developing and extending the department analytical capabilities with focus on physicochemical characterization of Biologics, as well as the occupational health and safety concepts for handling of high potent compounds
Functional and technical management of contract manufacturing organizations (CMOs) for clinical trials material manufacturing, as well as technology transfers to in-house manufacturing sites and CMOs in Europe, including on-site support
Supporting the team in creating and reviewing manufacturing protocols and reports
Support the preparation of regulatory submission documents; including NDA, and BLA.
Collaboration with various international multidisciplinary project teams (including colleagues from Japan, US and CMOs in Europe)

University degree in Pharmacy or related subject, ideally with PhD in Pharmaceutical Technology (focus on Lyophilization and Biologics)
At least two years of relevant work experience in pharmaceutical industry (formulation and process development).
Previous experiences with CMO management, global CMC development, technology transfer and handling of high potent biologics are preferable.
Experience in Design of Experiments and upscaling of GMP-compatible manufacturing processes (Fill and Finish)
Previous expertise in CMC regulatory requirements and submissions
Very good written and oral communication skills in English and German
Very good IT skills (MS Office, SAP etc.)