Associate Director, Analytical Project Lead (m/f/d)

Salary Range:

€88,300.00 - €164,100.00

 

Job Description 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. 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.

Location: Schaftenau, Austria
#LI-Hybrid
No relocation is on offer for this position

 

Job Description

Your key responsibilities are:

The Analytical Project Lead (APL) is the strategic lead for overall analytical development (AD) and is accountable for the analytical project strategy, integrated planning and agreed deliverables to the CMC team, including the scientific content of the development program.

• 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 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 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.
• 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
• Proven ability to lead project teams in a matrix environment, drive decisions and ensure accountability across functions
• 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
• Worked in interdisciplinary teams with excellent theoretical and scientific knowledge of product development

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

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. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

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). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

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:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

 

Skills Desired

Budget Management, Data Science, Process Simulation, Waterfall Model