Formulation Project Leader

vor 3 Wochen

Basel, Schweiz Novartis Vollzeit

Novartis is at the forefront driving innovation in this field, working on new ways to optimize the manufacturing process with a focus on sustainability, scalability and cost-efficiency in order to bring life-saving treatments such as Leqvio® to more patients in need.
Novartis Leqvio is a ground-breaking approach to lower LDL-C and it is the first-ever approved LDL-C-lowering siRNA-based therapy to address ASCVD.
More siRNA-based therapies are currently in early to late phase development. As a Formulation Project leader, you will be part of Formulation and Process Development group focus responsible for the formulation development and clinical supplies of this very exciting pipeline. Not only are we re imagining medicine but we are also impacting on, saving and improving quality of life.
Key Responsibilities
- Provide technical support for oligonucleotide formulation development and parenteral manufacturing including, but not limited to, design of experiments of parenteral oligonucleotide products, batch records, deviations, change controls, CAPAs, tech transfer, and reports.
- 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.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Ph.D. in Chemistry or related disciplines with 2+ years of biopharmaceutical experience in Oligonucleotide (mRNA, siRNA, ASO) or Biologic field (ADC, proteins) OR Master degree with 5+ years biopharmaceutical experience OR Bachelor degree with 8+ years biopharmaceutical experience respectively, with proven formulation development (parenteral, aseptic, solution and/or suspension) and manufacturing process or related expertise. Expertise and knowledge in extra hepatic oligonucleotide delivery preferable.
- Experience with aseptic Drug Product manufacturing of oligonucleotides including process transfer and QbD design.
- Experience with devices (pre-filling syringes, vial, combination product)
- Experience with in-use compatibility study and Instruction for use preparation.
- Experience with process development and regulatory issues parenteral Drug Product clinical-grade manufacturing a plus.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying

Imagine what you could do here at Novartis

**Division**

Global Drug Development

**Business Unit**

TECHNICAL R & D GDD

**Country**

Switzerland

**Work Location**

Basel

**Company/Legal Entity**

Novartis Pharma AG

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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