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von: Innovative Medicines
Senior Expert – Parenteral Formulation and Process Development
Join the Pharmaceutical Development (PHAD) Specialty Unit as a Senior Expert – Formulation Project Leader (FPL) for drug product formulation and process development of parenteral innovative medicines, especially xRNA therapeutics and radioligand therapies (RLT). Leads, owns and manages drug product project deliverables including scientific documentation, experimental design for the development of parenteral products (liquid and lyophilized), batch record reviews, deviations, change controls, CAPAs, technical transfer to clinical and commercial manufacturing sites, and scientific reports.
Represents a specific expertise and acts as technical expert for at least one development task, in-depth knowledge of Lyophilization will be an advantage
Authors source documents for regulatory submissions, review CMC modules in the area of expertise incl. D. in Pharmaceutical Sciences, Chemical engineering, Chemistry or related disciplines with 2+ years of experience in parenteral drug development, particularly with peptides, oligonucleotides (mRNA, siRNA, ASO), or Biologics OR Master degree with 5+ years of relevant experience
Experience with primary packaging and drug device combination products ( pre-filling syringes, autoinjectors) is a plus
Fluent English (both spoken and written) is essential
Why Novartis: Helping people with disease and their families takes more than innovative science.
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