Senior Expert

vor 5 Monaten

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
**About the Role**:
**Key Responsibilities**:
Your responsibilities include, but are not limited to:
- As member of global CMC analytical sub team and device sub team for your project(s) you are contact person & coordinator for all project-specific analytical tasks related to functional attributes of drug-device combination products at all levels (from component to drug product to final product); plan resource & budget for your project(s)
- Select testing laboratory in line with resource availability, capability and in/outsourcing strategy, e.g. laboratory of Global Device & Packaging Development (GDPD), Quality Control, Contract Research Organisation (CRO); lead outsourced analytical project activities at CROs and contribute to manage external partnership.
- Own drug-specific analytical methods (AMs) / parameter sheets (PSs), organise and align x-functional inputs (e.g. with Device/Pack Tech); define, organise, document AM/PS validation and transfer.
- Co-shape and co-author x-functional analytical CMC strategies and documents, e.g. drug product and final product stability strategy, protocols and reports; method validation and transfer status summaries, Analytical Specifications (AS); organize input to Justification of Specification (JoS) (from Device/PackTech and Human Factors Engineering (HFE))
- Contribute to and review regulatory documents, support product registrations incl. present at inspections.

**Essential Requirements**:

- Master or PhD in engineering or functional/chemical/bio analytics or equivalent and minimum 5 years’ experience in pharmaceutical industry in combination product development
- Proven knowledge in late phase parenteral analytical development; leadership experience in managing development projects, ideally in a global matrix environment, understanding and awareness of regulatory guidelines for combination product analytics, experience with current good manufacturing practice (cGMP) and relevant ISOs.
- Collaborative spirit, self-driven attitude, high level of learning agility
- Fluent in English (oral and writing)

**Why Novartis?**
- **You’ll receive**:

- In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 66.800/year (on a full-time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
- We are open for part-time and job-sharing models and support flexible and remote working where possible.
- **Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
- **Adjustments for Applicants with Disabilities**:

- **Join our Novartis Network**:
Division

Development

Business Unit

Pharmaceuticals

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Adjustments for Applicants with Disabilities**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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