Die ganze Ausschreibung von Novartis
Das ist der Job
Location: Schaftenau, Austria No relocation is on offer for this position.
Darum lohnt es sich
Summary 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 and inspiring Analytical Project Lead to join our team in Austria.
Your Key Responsibilities You represent AD on the CMC core team and lead the global analytical sub‑team with cross‑functional members, ensuring clear objectives, roles, timelines and decision‑making.
You set priorities for the analytical sub‑team, facilitate alignment across functions and ensure effective execution in a complex matrix organization. You support the growth of sub‑team members and motivate them through encouraging and servant leadership.
Proven ability to lead project teams in a matrix environment, drive decisions and ensure accountability across functions. Worked in interdisciplinary teams with excellent theoretical and scientific knowledge of product development. Benefits & Rewards The rewards of being part of our team go far beyond base pay and incentives.
We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
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.
In this role, you will drive the analytical development strategy for late phase biologics projects and ensure effective project planning, cross‑functional coordination and timely delivery of key milestones in support of our biologics product pipeline.
You drive integrated analytical project plans, monitor progress against milestones, proactively identify risks, dependencies and bottlenecks, and define mitigation actions to secure delivery. You lead and coordinate timely delivery of high‑quality source documents for submissions, review regulatory documents (e.g.
CMC modules, briefing books) and interact with Health Authorities in audits and scientific advice meetings. You proactively communicate overall project strategy, project status, risks and priorities to key stakeholders and consolidate resource needs, including internal and external costs.
You lead and manage all analytical activities related to drug product and drug substance development, including release and stability testing, characterization of the API, method development, transfer and validation, specification setting and know‑how transfer.
You critically evaluate results, draw relevant conclusions and translate scientific input into clear project decisions. What You Will Bring To The Role PhD and minimum of 8 years relevant experience in 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 in IND/BLA submissions.
Strong project management skills, including planning, milestone tracking, prioritization, risk management, stakeholder alignment and delivery of complex cross‑functional activities. Ability to navigate and deliver effectively in a highly dynamic environment with changing priorities and evolving project needs. Proficiency in English.
Proven track record of creativity, problem solving and productivity. Proficient scientific/technical writing skills. Desirable Requirements Demonstrated excellent communication, presentation and stakeholder management skills.
Experience in managing complex development projects, including integrated planning, resource coordination and risk mitigation. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
In accordance with Austrian law, the minimum salary for this position is €78 383.90 per year (on a full‑time basis); actual salary may be higher.
Adjustments For Applicants With Disabilities If, because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information.
The support will include advice on suitable positions as well as guidance at all stages of the application process.
Bereit?
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