Senior Expert
vor 6 Monaten
**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.
-
Senior Expert Engineering
vor 2 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: LOCATION: Schaftenau, TYPE: Hybrid Working, #LI Hybrid Are you looking for a challenging and rewarding career in Combination Product Development with a brand new device? Do you want to be part of a team of talented and passionate engineers and scientists who are responsible for the development of parenteral combination products to ensure that...
-
Senior Expert, Biologics Analytical Operations
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit386345BR **Senior Expert, Biologics Analytical Operations (M/F/d)**: Austria **About the role** **Senior Expert (f/m/d), Analytical Operations, Schaftenau, Austria, #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. This will include investigating the stability behavior...
-
Senior Process Expert
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit391268BR **Senior Process Expert (f/m/d)**: Austria **About the role** **Location**:Austria, Schaftenau As a **Senior Process Expert**, you will provide front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines...
-
Senior Process Expert
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**About the Role**: **Location**:Austria, Schaftenau As a **Senior Process Expert**, you will provide front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE) and to...
-
Senior QA Compliance Expert
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: As Senior QA Compliance Expert you will support, facilitate and drive on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the Campus products to ensure timely supply to the markets in compliance with current regulatory obligations and...
-
Senior Expert Science
vor 3 Wochen
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: As a Senior Expert you will be part of a team developing new Biologic drugs. Analytical Operations is the team releasing the product for clinical trial and investigating the stability behavior of the drugs. Furthermore, we are validating the methods used for release and will be also responsible for transferring the methods to our commercial...
-
Senior Expert, Biologics
vor 6 Monaten
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...
-
Senior Expert, Biologics Analytical Operations
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: As a Senior Expert you will be part of a team developing new Biologic drugs and the release of product for clinical trials. This will include investigating the stability behavior of the drugs. The role will be a mix of overseeing development, authoring/completing documentation and working at the bench when necessary. As such, you should be...
-
Senior Expert Science
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: Drug Product Development Senior Expert Science & Technology (M/F/d), Schaftenau, Austria, #LI-Hybrid. About the Role: We are looking for a passionate Scientist with a background or interest in Modelling & Simulation to join our team and lead a wide range of activities from formulation and process development to technical transfer and submission...
-
Senior Expert, Biologics Analytical Operations
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: As a Senior Expert you will be part of a team developing new Biologic drugs and the release of product for clinical trials. This will include investigating the stability behavior of the drugs. The role will be a mix of overseeing development, authoring/completing documentation and working at the bench when necessary. As such, you should be...
-
Process Expert
vor 2 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: Process Expert (M/F/d ) Location: Schaftenau, Tyrol, #LI-Hybrid We are seeking a Process Expert (M/F/d ) to help us to ensure execution of processes, and to allow continuous improvements in quality, productivity, and efficiency. This role will work directly with the Process Support Unit and reports to the Senior Process Expert. **About the...
-
Senior Process Expert
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: ~Prozessteamleiter mittlerer/kleiner Standort Beaufsichtigt den täglichen Betrieb innerhalb der Produktionseinheit in einer Weise, die mit einer Kultur der Selbststeuerung (Befähigung und Verantwortlichkeit) vereinbar ist, um qualitativ hochwertige Produkte auf konforme, effiziente und kostengünstige Weise herzustellen und an Kunden zu...
-
Senior Process Expert
vor 2 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: - Shift Lead II Der Shift Leader ist verantwortlich für die Verwaltung seines Teams, um die Fertigung nach Zeitplan in Übereinstimmung mit den HSE- und GMP-Regeln durchzuführen. Prozessexperte - Bereitstellung technischer und wissenschaftlicher Expertenunterstützung an vorderster Front für alle prozessspezifischen Fragen, um die...
-
Senior Expert
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit394730BR **Senior Expert - Device Project Analyst (f/m/d)**: Austria **About the role** **Location: Schaftenau, Austria, Hybrid Working #LI-Hybrid** **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...
-
Senior Process Expert
vor 6 Monaten
Langkampfen, Österreich Novartis VollzeitLocation: Austria, SchaftenauAs a Senior Process Expert, you will provide front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE) and to continuously improving in...
-
Mass Spectrometry Expert Science
vor 1 Monat
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: ~Entwerfen, Planen, Durchführen, Interpretieren und Berichten von Ergebnissen wissenschaftlicher Experimente zur Vorbereitung und rechtzeitigen Abgabe von Wirkstoffen (DS), Arzneimitteln (DP), Prozessen und Verfahren innerhalb eines multifunktionalen Projektteams, das von einem Projektleiter koordiniert wird. Verwalten Sie technische...
-
Senior Expert Engineering
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: **About the Role**: **Key Responsibilities**: - Own and run packaging design for secondary & tertiary packaging activities (incl. labelling) in global cross functional teams to launch new products and redesign on market products. - Lead packaging design projects for technology platforms and manage collaboration with involved functions to ensure...
-
Senior Expert Science
vor 3 Wochen
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: LOCATION: Schaftenau, Austria TYPE: Hybrid Working, #LI-Hybrid **About the Role**: **Your** key** responsibilities**: - Design, supervise and coordinate analytical development activities for assigned projects, manage multiple tasks simultaneously, meet customer needs. - Lead analytical method development, provide scientific guidance for the...
-
Project and Portfolio Excellence Senior Expert Trd
vor 6 Monaten
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: **About the Role**: **Key Responsibilities**: - Manage the external costs planning for assigned drug development projects including cost forecasting, tracking, rephasing, and reporting. - Demonstrate full cost awareness. Review and validate cost planning input received from the development team members and partners. - Proactively liaise with...
-
Team Leader
vor 3 Wochen
Langkampfen, T, Österreich Novartis Vollzeit**Summary**: LOCATION: Schaftenau, Austria TYPE: Hybrid Working, #LI-Hybrid As Senior manager of the Lab Automation team you will lead a team in Process Analytical Sciences (PAS) at our TRD Biologics site in Schaftenau (AT). **About the Role**: **Your responsibilities** - Include, but are not limited to: - Acts as operational manager for a medium sized...