345883BR
Sep 14, 2022
Austria

Job Description

200! This the current number of programs in clinical development at Novartis.
Many of these projects, which include new molecular entities, Biosimilars, as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.

We are a global team of highly skilled analytical project managers with presence in all biologics technical research and development sites of Novartis in Europe, and we are looking for you as an experienced, curious, inspiring Analytical Project Leader to join our team to support development of our biologic product pipeline.

Your key responsibilities are:
The Analytical Project Leader (APL) is the strategic lead of overall analytical development (AD) and is accountable for agreed upon deliverables to the CMC team, the scientific content of development program
• You represent AD 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

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you will bring to the role
• 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

We are looking for responsible, objective-driven candidates who value collaboration, team work and are open to new challenges and expanding their knowledge and expertise.

We offer permanent contract with 6 months of probation period, work in a dynamic environment, collaboration with different teams, knowledge and experience sharing within the global Novartis system
Global Drug Development
TECHNICAL R & D GDD
Austria
Schaftenau
Germany
Research & Development
Full Time
Regular
No
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345883BR

Analytical Project Lead - Associate Director

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