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Senior Expert, Biologics

vor 4 Wochen

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
Senior Expert, Biologics - Visual Inspection, Analytical Operations, Schaftenau, Austria, Hybrid role, #LI-Hybrid As a Senior Expert you will be part of a team developing new Biologic drugs and the release of product for clinical trials. A key aspect of the role will be involvement in Global discussions on the methods and processes for Visual Inspection of pharmaceutical products including vials, syringes/injectables etc. The aim will be the harmonisation and compliance to global and local standards in the area of Visual Inspection. As the Subject Matter Expert (SME) you will also be expected to deliver ongoing training of Visual Inspection to operators within the group. The role will be a mix of Visual Inspection work and overseeing development, authoring/completing documentation and working at the bench when necessary. As such, you should be comfortable working in a hybrid environment both in and out of the lab.

**About the Role**:
**Key responsibilities**:
Your responsibilities include, but are not limited to:
- To be the SME for Visual Inspection on site
- Working with Global Teams on the development of Visual Inspection methods to ensure compliance to Global and local standards.
- Writing protocols, scientific reports, lab procedures and providing training for Visual Inspection.
- Supporting the lab team in case of troubleshooting existing methods, processes, or solving problems of higher complexity within projects
- Independently managing key tasks for projects (e.g. release, stability studies, validation and transfer activities)
- Writing protocols, scientific reports, lab procedures and providing ready-to-submit documents intended for submissions (e.g. release or stability documents, transfer reports)
- Approving GMP documents and test records as well as investigating quality events within the project (e.g. deviations, changes, out-of-specifications events).

**Essential Requirements**:

- Master Degree in biotechnology, biochemical engineering, biology, chemistry, biochemistry or similar with at least 4 years strong relevant industry experience or PhD in relevant field or equivalent and 2+ years of work experience within the pharmaceutical industry
- Strong knowledge and experience gained in the Visual Inspection of pharmaceutical product (beneficial)
- Proficiency in English (German is beneficial)
- Good knowledge of sound technical & scientific of pharmaceutical, chemical analytics, QC or equivalent
- Good knowledge of sound technical & scientific of pharmaceutical, chemical analytics, QC or equivalent
- Proven experience within GMP environment
- Good theoretical and scientific knowledge in the area of expertise (like HPLC, CE)
- Good experience of delivering training.

**Desirable requirements**:

- A personality with a can-do mind-set and the ability to adopt to change with strong communication across organizational interfaces and presentation skills
- Ability to work and lead (a cross-functional team) in a matrix environment

**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 €60,212.18/year (on a full-time basis). The actual salary will be significantly 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.