Analytical Project Lead

**Summary**:
Analytical Project Lead, LOCATION: Schaftenau, Austria or Mengeš, Slovenia, #LI-Hybrid 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. We are looking for you as an experienced, curious, inspiring Analytical Project Leader (APL) to join our team to support development of our biologic product pipeline. The APL is the strategic lead of overall analytical development (AD) and is accountable for agreed upon deliverables to the Chemistry Manufacturing & Controls (CMC) team and the scientific content of development program.

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

- Representing AD on the CMC core team & lead the global analytical sub-team with cross functional members
- Leading and coordinating timely delivery of high quality source documents for submission, review of regulatory documents (e.g. CMC modules, briefing books) and interactions with Health Authorities in audits and scientific advice meetings
- Supporting the growth of the sub-team members and motivating them as appropriate by encouraging and servant leadership
- Leading and managing all analytic related activities of drug product and drug substance development including release and stability-testing, characterization of the active pharmaceutical ingredient (API), method-development, -transfer and -validation, specification setting, know-how transfer etc., critically evaluating results and drawing relevant conclusions
- Communicating effectively across organizational interfaces i.e. project-management, line functions, senior management, etc.
- Proactively identifying scientific, technological and Good Manufacturing Practice (GMP) issues, proposing creative solutions and communicating key issues to the appropriate management level
- Responsibility for analytical budget and resource planning

**Essential 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 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 €89,600 per 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.