Drug Product Project Leader

**Summary**:
LOCATION: Schaftenau, Austria
ROLE TYPE: Hybrid Working, #LI-Hybrid

Join our global team of highly skilled Drug Product Project Leaders with presence in all technical research and development sites for Biologics at Novartis We seek an experienced, curious and resilient leader to drive the late-stage drug product development of our biologics product pipeline.

As Drug Product Project Leader in Austria, you will be the strategic lead of drug product development of Biologics and be accountable for agreed upon deliverables to the CMC team. Enjoy an inspired environment with a clear purpose in an impactful role - bringing innovation to patients and to the market

**About the Role**:
**Your responsibilities include**:

- Lead the technical development strategy for complex biologics, representing Drug Product Development in the global Chemistry Manufacturing Controls (CMC) team and ensuring delivery of agreed milestones
- Champion scientific excellence in the CMC team regarding drug product formulation and process development, technical transfers, process validation and registration of the biological product
- Lead and coordinate the global drug product sub-team (functional experts from e.g. formulation and process development, Analytics, Production, Device Development or Regulatory), fostering the growth of sub-team members through servant leadership and coaching
- Be accountable for timely delivery of high quality source documents for submission, review of regulatory documents (CMC modules, briefing books) and interact with Health Authorities (e.g. requests for information and inspections)
- Setting priorities for the drug product sub-team
- Proactively communicate the overall project strategy and requirements, ensuring effective stakeholder engagement across CMC teams, sub-teams, line functions, and internal/external partner functions (e.g. Governance boards, Technical Operations, Regulatory CMC, Device and Packaging Development, contracted partners)
- Assess and consolidate resource and project budget needs
- Strategically evaluate and integrate external assets for Drug Product Development (in-licensing, Mergers & Acquisitions (M&A)) in line with portfolio strategy

**What you’ll bring to the role**:

- Ph.D. in pharmaceutical technology, biotechnology, chemical engineering or equivalent
- Minimum of 8 years of relevant industry experience with a focus on drug product formulation and process development, technology transfers and regulatory submissions
- Proficient in quality principles, Quality by Design (QbD), Good Manufacturing Practice (GMP) and regulatory requirements with experience in Investigational New Drug (IND) / Biologics License Application (BLA) submissions
- Excellent leadership and interdisciplinary skills, with a track record of leading cross-functional global teams and projects
- Excellent project management, communication / presentation, stakeholder management and scientific / technical writing skills
- Openness to digital transformation and proactiveness in adopting new digital tools and Artificial Intelligence (AI)-driven solutions
- Strategic mindset with strong business acumen
- Fluency in English (oral and written)

We value responsible, objective-driven and resilient professionals who thrive in collaborative, cross-functional environments and are eager to embrace new challenges and expand their expertise.

**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 €78,383.90 /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**:
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

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.