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Analytical Validation Specialist/CMC Specialist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
290300/1
IHRE AUFGABEN:
-Review of existing analytical methods
-Scoping of analytical method validation in collaboration with the CMC PM, the CMC management team and the CMOs
-Input to overall validation strategy and timelines
-Review of analytical method validation protocols
-Technical support and troubleshooting during wet work in collaboration with CMOs
-Review of analytical method validation reports
IHRE QUALIFIKATIONEN:
-Demonstrated experience in analytical method validation, writing of regulatory filing documents and development of biologics and/or monoclonal antibodies is preferred
-As you are expected to actively participate at CMC management team and on-site visits at the CMO, good collaboration and communication skills are a prerequisite
-Fluency in English
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
290300/1
IHRE AUFGABEN:
-Review of existing analytical methods
-Scoping of analytical method validation in collaboration with the CMC PM, the CMC management team and the CMOs
-Input to overall validation strategy and timelines
-Review of analytical method validation protocols
-Technical support and troubleshooting during wet work in collaboration with CMOs
-Review of analytical method validation reports
IHRE QUALIFIKATIONEN:
-Demonstrated experience in analytical method validation, writing of regulatory filing documents and development of biologics and/or monoclonal antibodies is preferred
-As you are expected to actively participate at CMC management team and on-site visits at the CMO, good collaboration and communication skills are a prerequisite
-Fluency in English
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland