Formulation Project Leader xRNA Therapeutics - Senior Expert

Job Description Summary

Job Description

Major accountabilities:

• Be accountable for all formulation and manufacturing process deliverables including scientific documentation, design of experiments of parenteral products, batch records, deviations, change controls, CAPAs, tech transfer, and reports.
• Drive DP development, manufacturing process transfers and supply activities with scientific and technological excellence  
• Work closely with cross functional teams both internal and external to provide technical input for the development and manufacturing process (including CRO and CMOs).
• Provide technical support to compile technical regulatory documentation and responses to regulatory agencies as needed.
• Assist with writing and reviewing of CMC documentation associated with project or manufacturing changes.

Key Skills

• Formulation Expertise: Experience developing injectable drugs, including solutions, suspensions, and aseptic formulations. Knowledge of RNA-based therapies (e.g., siRNA, mRNA) and drug delivery systems like pre-filled syringes or vials.
• Process Development: Skills in designing manufacturing processes and transferring them to production environments. Familiarity with aseptic drug manufacturing and methods like QbD.
• Regulatory Knowledge: Understanding of GMP and preparing technical documentation for regulatory submissions.
• Analytical Thinking: Designing experiments (e.g., DoE) and analyzing data to improve formulations and manufacturing processes.
• Collaboration & Communication: Strong teamwork skills for working with internal teams and external partners (e.g., CROs/CMOs). Clear communication and ability to write reports, technical documents, and regulatory responses.
• Problem-Solving: Ability to handle deviations, implement corrective actions, and improve manufacturing processes.
• Innovation: Interest in advancing RNA drug delivery platforms and contributing new ideas to the field.

Preferred Technical Experience

• Working knowledge of oligonucleotide-based therapies (e.g., ADCs, proteins, RNA-based drugs).
• Familiarity with process development for clinical-grade parenteral drug products. Proven experience in related fields such as pharmaceuticals, biotechnological product development, and advanced drug delivery platforms.

Required Qualifications:

• Ph.D., Master’s or Bachelor’s Degree in Chemistry or related disciplines: With 2+ years (Ph.D.), 5+ years (Master’s), or 8+ years (Bachelor’s) biopharmaceutical experience.
• Proven expertise in formulation and manufacturing process development for parenteral and aseptic products.

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 inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
 

Skills Desired