Associate Director

**Summary**:
~Management-Spur
Dies ist eine universelle Stellenbeschreibung, die einige der primären Aufgaben dieser Rolle erfassen soll, die in allen Funktionen oder Abteilungen üblich sind. Es ist nicht beabsichtigt, alle spezifischen Verantwortlichkeiten der Position zu repräsentieren.
Leitung einer Funktion für die Entwicklung von pharmazeutischen/biologischen/Zell-Gen-Therapien in einer multidisziplinären Einheit oder GMP-Einrichtung. Gestalten und entwickeln Sie die strategische Ausrichtung und treiben Sie die operative Exzellenz im Einklang mit der Vision und Strategie von TRD voran. Sicherstellung der vollständigen Portfoliounterstützung im Einklang mit den Plänen von GDD, Sandoz, NTO und NIBR.

~Wissenschaftlicher / technischer Track
Leitet und verwaltet alle Projekt-/Netzwerkaktivitäten und wendet wissenschaftliches/technisches Fachwissen an, um komplexe RandD-Probleme anzugehen und TRD-Strategien und -Ziele aktiv zu unterstützen, indem er an funktionsübergreifenden Teams teilnimmt. Leitung wissenschaftlicher Programme; koordinieren interdisziplinäre Projekte und Teams. Entwicklung langfristiger Strategien für Wissenschaft und Technologien.

~SANDOZ:
~Leitet und verwaltet alle Projektaktivitäten und wendet wissenschaftliches/technisches Fachwissen an, um komplexe Entwicklungsprobleme anzugehen. Unterstützt aktiv die Strategien und Ziele von Sandoz durch die Teilnahme an funktionsübergreifenden Teams. Leitet wissenschaftliche Programme; koordiniert interdisziplinäre Projekte und Teams. Entwickelt langfristige Strategien für Wissenschaft und Technologien.

**About the Role**:
**Key Responsibilities**:
Your responsibilities include but are not limited to:

- Represent GDPD in CMC sub-teams, leading device-related discussions and securing endorsement for project strategy or changes.
- Lead cross-functional project teams, acting as a single point of contact (SPOC) for all device and packaging related issues.
- Plan, manage, and control project resources, schedules, and budgets.
- Assess and negotiate internal & external resource needs on an ongoing basis. Establish and maintain a high-quality Design History File for developments and LCM projects until transfer to manufacturing sites.
- Ensure compliance with internal process requirements and current regulations, including Design Control, CMC, FDA combination product regulations and ISO requirements.
- Contribute to the improvement of process and delivery technology approaches.
- Evaluate suitable device technology to support different project phases.
- Support internal and external audits on packaging and medical device related matters.
- Assist teams in regulatory dossiers preparation, including documents for medical device/combination product registration and in responding to health authority queries.

**Essential Requirements**:

- Master or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent.
- Minimum 5-10 years of experience in the pharmaceutical industry, preferably in drug-device combination product technical development including technical operations.
- Ability to work and lead a cross-functional team in a matrix environment
- Proven knowledge and track record in project and program planning and execution
- Understanding and awareness of regulatory guidelines for drug-device combination products, including relevant ISOs and current good manufacturing practices (cGMP).
- Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker.
- Fluent in English (oral and writing), German is beneficial

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 € 77 543,90 /year (on a full-time basis). 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

Innovative Medicines

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regulär

Shift Work

No

**Unterstützungen für BewerberInnen mit Behinderungen*