Associate Director Analytical Development Project

Vor 4 Tagen

Langkampfen T, Österreich Novartis Vollzeit

We are looking for an Associate Director of Analytical Development Program Management to join a global team of highly skilled analytical project managers with presence in all biologics technical research and development sites of Novartis in Europe. We are looking for you as an experienced, curious, inspiring Analytical Project Leader to join our teams in Austria to support development of our biologic product pipeline.
The Associate Director is the strategic lead of overall Analytical Development and is accountable for agreed upon deliverables to the CMC team, the scientific content of development program
Key responsibilities
- You represent Analytical Development on the CMC core team & lead the global analytical sub-tem with cross functional members
- You lead and coordinate timely delivery of high quality source documents for submission, review of regulatory documents (e.g. CMC modules, briefing books) and interact with Health Authorities in audits and scientific advice meetings
- You will need to proactively communicate overall project strategy, asess and consolidate resource needs (internal and external costs) and set priorities for the analytical subteam
- You support the growth of the sub-team members and motivates them as appropriate by encouraging and servant leadership
- You lead and manage all analytic related activities of drug product and drug substance development including release and stability-testing, characterization of the API, method-development, -transfer and -validation, specification setting, know-how transfer etc., critically evaluate results and draw relevant conclusions

We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group.
The minimum salary for this position is €85,600 per year (on a full-time basis).

**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**
- PhD and minimum of 8 years relevant experience of Biologics CMC development or University life-science degree with appropriate industry experience
- Previous experience in analytical areas in biologic drug development in an industrial setting
- Excellent understanding of regulatory expectations and requirements with significant experience with IND/ BLA submission
- Proficiency in English
- Proven leader with minimum of 5 years experience in managing teams/ projects
- Proven track record of creativity, problem solving and productivity
- Proficient scientific/technical writing skills

Desirable Requirements:

- Demonstrated excellent communication, presentation and management skills
- Worked in interdisciplinary teams with excellent theoretical and scientific knowledge of product development

Why consider Novartis?

769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

**Division**

Global Drug Development

**Business Unit**

TECHNICAL R & D GDD

**Country**

Austria

**Work Location**

Schaftenau

**Company/Legal Entity**

Sandoz GmbH

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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