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Principal Scientist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Engineering
Projektbeschreibung
REFERENZNUMMER:
296145/11
IHRE AUFGABEN:
-Develop formulations and manufacturing processes for parenteral dosage forms of biologics for the clinic, market and for lifecycle products as a member of the Biologics Process R&D late phase team
-Responsibility for transferring the manufacturing process to the clinical and commercial manufacturing site internally or externally
-Act as subject matter expert for pharmaceutical development
-Represent pharmaceutical development in the technical CMC teams of the assigned projects
-Work closely with your colleagues in pharmaceutical operations, device development, analytics and quality Support technology evaluations as requested and proactively identify and realise opportunities for invention disclosures in portfolio and technology projects assigned
-Support the assigned due diligence activities
-Represent the client externally in industry consortiums and scientific meetings
IHRE QUALIFIKATIONEN:
-PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or in a related discipline
-Pharmaceutical functional expert in Biologics
-Profound experience in the pharmaceutical development of biologics (formulation & manufacturing process), preferably in late phase development
-Hands-on experience in transferring manufacturing processes
-Experience in filings with health authorities, preferably with BLAs/MAAs
-Understanding of quality control (cGMP), including production aspects
-Experience in design of experiment (DoE) and using statistical programs
-Demonstrated ability to work in interdisciplinary technical teams with project management skills
-Excellent communication skills
-Scientific and entrepreneurial thinking
-Excellent English skills (oral and written), skills in German are of advantage (oral)
WEITERE QUALIFIKATIONEN:
R&D scientist
296145/11
IHRE AUFGABEN:
-Develop formulations and manufacturing processes for parenteral dosage forms of biologics for the clinic, market and for lifecycle products as a member of the Biologics Process R&D late phase team
-Responsibility for transferring the manufacturing process to the clinical and commercial manufacturing site internally or externally
-Act as subject matter expert for pharmaceutical development
-Represent pharmaceutical development in the technical CMC teams of the assigned projects
-Work closely with your colleagues in pharmaceutical operations, device development, analytics and quality Support technology evaluations as requested and proactively identify and realise opportunities for invention disclosures in portfolio and technology projects assigned
-Support the assigned due diligence activities
-Represent the client externally in industry consortiums and scientific meetings
IHRE QUALIFIKATIONEN:
-PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or in a related discipline
-Pharmaceutical functional expert in Biologics
-Profound experience in the pharmaceutical development of biologics (formulation & manufacturing process), preferably in late phase development
-Hands-on experience in transferring manufacturing processes
-Experience in filings with health authorities, preferably with BLAs/MAAs
-Understanding of quality control (cGMP), including production aspects
-Experience in design of experiment (DoE) and using statistical programs
-Demonstrated ability to work in interdisciplinary technical teams with project management skills
-Excellent communication skills
-Scientific and entrepreneurial thinking
-Excellent English skills (oral and written), skills in German are of advantage (oral)
WEITERE QUALIFIKATIONEN:
R&D scientist
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges