Formulation Project Leader xRNA Therapeutics - Senior Expert

• 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.

• 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.

• 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.

• 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.

Novartis