Job Description Summary Are you an Analytical Expert who can demonstrate creativity in the field of analytical science and technology and with an interest in analytical lifecycle management.? We are looking for an expert who can support not only our current and but also future analytical control strategies for new chemical entities ensuring long-term supplies to our patients. We play a meaningful role in the late phase delivery, launch and lifecycle management of small molecule drug substances.Job DescriptionMain responsibilities:
Analytical expert supporting launch and lifecycle management of projects in collaboration with the analytical project lead and multiple partners
Manage product specifications including the design, development, validation, transfer and performance monitoring of analytical procedures/technologies
Good understanding of scientific, regulatory and quality standards
Ensure training according to cGMP requirements
Maintain excellent planning and collaboration with internal and external stakeholders (e.g. laboratory analysts, production specialists, manufacturing science and technology, quality assurance, regulatory CMC, project leaders, colleagues and third parties)
Design and plan analytical experiments. Interpret and report results in preparation for timely delivery of project milestones
Support change control, preparation of the regulatory dossier and health authority inspections
Support root cause investigations (deviations / OOX)
Languages :
German
English.
Skills Desired Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Managing Resources, Organizational Savvy, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Smart Risk Taking, Technological Expertise, Total Quality Management
