Key Responsibilities:  

• 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.
• Core member of the drug product sub-team representing scientific/technical excellence, ad hoc member of global CMC team
• Represents a specific expertise and acts as technical expert for at least one development task, in-depth knowledge of Lyophilization will be an advantage
• Contributes to answering health authority questions
• Authors source documents for regulatory submissions, review CMC modules in the area of expertise incl. data integrity checks
• Works closely with cross functional teams both internally and externally to provide technical input for development and manufacturing (including CRO and CMOs).
• Stays at the forefront of scientific & technical trends, leads initiatives to optimize current work practices, leads or contributes to scientific work streams

Role Requirements: 

• Ph.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
• Demonstrated experience in parenteral formulation and process development (especially Lyophilization incl. strong foundation in theoretical aspects and modelling)
• Experience with process transfer to GMP manufacturing sites (incl. familiarity with QbD principles)

Desirable Skills: 

• Experience with primary packaging and drug device combination products (pre-filling syringes, autoinjectors) is a plus
• Experience with regulatory submissions is a plus 

Languages: 

• Fluent English (both spoken and written) is essential   
• Additional languages are an advantage 

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.