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Specialist Analytical Methods for Small Molecule APIs (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
270900/11
IHRE AUFGABEN:
-Supervision and support of analytical development work at CMOs
-Responsible for an appropriate development of analytical methods to collect all the necessary data for a successful development at external partners
-Collection, interpretation and documentation of necessary analytical data for submission to health authorities
-Preparation of regulatory base documents for submission to the health authorities
-Preparation of specifications for raw materials, in-process-controls, intermediates and final APIs
-Supervision of stability studies performed at CMOs
-If necessary, leading an analytical laboratory with 2-4 technicians
-Participation in project teams and interdisciplinary collaboration with international teams from different functions (e.g. research, drug product analytics, internal and external QA organisations, CMO organisations, and regulatory departments)
IHRE QUALIFIKATIONEN:
-You have in-depth training in analytical or organic chemistry, preferably at PhD level, and already have profound experience in the pharmaceutical development
-You have experience in drawing up regulatory documents for IND/NDA submissions
-Ideally you also have experience in collaborating with external partners
-Your profile is rounded off by a communicative and resilient personality, good IT skills, a very good command of spoken and written English and the willingness to learn German
WEITERE QUALIFIKATIONEN:
Head of laboratory
270900/11
IHRE AUFGABEN:
-Supervision and support of analytical development work at CMOs
-Responsible for an appropriate development of analytical methods to collect all the necessary data for a successful development at external partners
-Collection, interpretation and documentation of necessary analytical data for submission to health authorities
-Preparation of regulatory base documents for submission to the health authorities
-Preparation of specifications for raw materials, in-process-controls, intermediates and final APIs
-Supervision of stability studies performed at CMOs
-If necessary, leading an analytical laboratory with 2-4 technicians
-Participation in project teams and interdisciplinary collaboration with international teams from different functions (e.g. research, drug product analytics, internal and external QA organisations, CMO organisations, and regulatory departments)
IHRE QUALIFIKATIONEN:
-You have in-depth training in analytical or organic chemistry, preferably at PhD level, and already have profound experience in the pharmaceutical development
-You have experience in drawing up regulatory documents for IND/NDA submissions
-Ideally you also have experience in collaborating with external partners
-Your profile is rounded off by a communicative and resilient personality, good IT skills, a very good command of spoken and written English and the willingness to learn German
WEITERE QUALIFIKATIONEN:
Head of laboratory
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges