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 Description
Main 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 :
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
Required Experience:
Senior IC
Job Description SummaryAre 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 stra...
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 Description
Main 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 :
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
Required Experience:
Senior IC
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