Formulation Project Leader xRNA Therapeutics - Senior Expert

Join Our Team in Pharmaceutical & Analytical Development

Be a part of cutting-edge parenteral drug product development and contribute to the advancement of novel technology platforms such as Oligonucleotides at Novartis main Campus in Basel, Switzerland. This opportunity allows you to make a significant impact in the biopharmaceutical field and be at the forefront of bringing life-changing medicines to patients worldwide.

Key Responsibilities

• Accountable for all formulation and manufacturing process deliverables including scientific documentation, design of experiments for parenteral products, and batch records.
• Drive drug product development, manufacturing process transfers, and supply activities with scientific and technological excellence.
• Collaborate closely with cross-functional teams, both internal and external, to provide technical input for the development and manufacturing processes.
• Provide technical support to compile technical regulatory documentation and responses to regulatory agencies as required.
• Assist in writing and reviewing CMC documentation associated with projects or manufacturing changes.

Preferred Qualifications and Skills

• Formulation Expertise: Experience in developing injectable drugs, including solutions, suspensions, and aseptic formulations, with knowledge of RNA-based therapies and drug delivery systems.
• Process Development: Skills in designing manufacturing processes, with familiarity in aseptic drug manufacturing and methods like Quality by Design (QbD).
• Regulatory Knowledge: Understanding of Good Manufacturing Practices (GMP) and preparing technical documentation for regulatory submissions.
• Analytical Thinking: Capable of designing experiments and analyzing data to improve formulations and manufacturing processes.
• Collaboration & Communication: Strong teamwork skills with effective communication abilities for writing reports and technical documents.
• Problem-Solving: Proficient in addressing deviations, implementing corrective actions, and enhancing manufacturing processes.
• Innovation: A keen interest in advancing RNA drug delivery platforms and contributing new ideas to the field.

Education and Experience

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

Our Commitment to Diversity and Inclusion

We are dedicated to fostering an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities we serve.

Why Novartis?

Helping people with disease and their families requires more than just innovative science. It takes a community of smart, passionate individuals working together to achieve breakthroughs that change patients' lives. Join us in creating a brighter future.

Benefits and Rewards

Explore various ways we support your personal and professional growth.

Location

Basel, Switzerland

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