Analytical Project Lead, Biosimilar CDMO (m/f/d)

Novartis; Schweiz; Hybrid; CHF 61.000 - 110.000; Vollzeit

Benefits dieser Stelle

Company pension

Childcare facilities

Learning & development opportunities

Worldwide career possibilities

Zusammenfassung

Novartis is seeking an Analytical Project Lead to provide analytical leadership for biosimilar programs as the CDMO within a global development setting. You will lead analytical strategy, oversee method development and transfer, and coordinate cross-functional teams across Novartis sites and contract laboratories.

The role requires strong project management, matrix leadership and effective stakeholder management, with fluency in English and a track record in biologics CMC development.

Qualifikationen

• PhD in life sciences, biotechnology, biochemistry, pharmaceutical sciences or a related discipline, with relevant pharmaceutical industry experience, or an equivalent scientific degree with substantial relevant experience.
• Strong experience in biologics CMC development, including experience in analytical development and project leadership particularly in late staged development.
• Demonstrated ability to lead complex, global and cross-functional development projects in a matrix organization without direct authority.
• Broad scientific and technical understanding of analytical development for biologics.
• Project management capabilities, including integrated planning, scope and change management, risk management, resource and budget planning, stakeholder alignment and milestone delivery.
• Good understanding of global regulatory expectations for biologics development and experience contributing to regulatory submissions and health authority interactions.
• Good communication, influencing and stakeholder management skills, with the ability to build effective customer relationships and navigate organizational interfaces.
• Ability to identify critical issues, develop pragmatic solutions, drive decisions and maintain delivery focus in a dynamic environment.
• Proficient scientific and technical writing skills and fluent English, written and spoken.

Aufgaben

• Act as the Analytical Project Lead for assigned biosimilar programs and represent Novartis Analytical Development in the global CMC project team.
• Lead the global, cross-functional analytical sub-team in a matrix setup and align on objectives, priorities, timelines, interfaces and decisions.
• Translate the Statement of Work and agreed customer deliverables into executable analytical plans, milestones, resource requirements and decision points.
• Ensure delivery of analytical work packages by Novartis as the CDMO, in accordance with agreed scope, quality standards, timelines and governance. Proactively manage dependencies, risks, changes and escalation needs.
• Ensure transparent communication of strategy, progress, risks, scientific recommendations and decisions while maintaining clear accountability between customer and CDMO roles.
• Provide scientific and technical oversight of analytical activities performed within Novartis and, where required, at contract laboratories, including analytical method development, validation and transfer, specification setting, release testing and stability programs.
• Lead the preparation and review of high-quality analytical source documents and contributions supporting regulatory submissions, health authority interactions, scientific advice, audits and inspections.
• Be accountable for identifying scientific, technical or GMP issues, and drive robust, science-based solutions and timely decisions.
• Be accountable for analytical resource and budget needs, support financial planning and tracking, and manage delivery within the agreed project framework.
• Communicate project status, priorities, risks, resource needs and recommendations effectively to senior stakeholders and relevant governance bodies.
• Foster a collaborative, accountable and solution-oriented working environment across Novartis Development and external partners.

Kenntnisse

Analytical project leadership

Cross-functional leadership

Biologics CMC development

Regulatory submissions

Communication skills

Scientific writing

English proficiency

Ausbildung

PhD in life sciences or related

Jobbeschreibung

Salary Range: €66,918.00 - €117,800.00

Job Description Summary

We are a global team of analytical project leaders within Novartis Development, supporting the development of biologic medicines across a complex, cross-functional environment. We are seeking an Analytical Project Lead to provide analytical leadership for biosimilar programs that Novartis develops as a CDMO.

In this role, you will be accountable for delivering the analytical development strategy and its execution within the agreed Statement of Work. You will represent the Novartis Analytical Development in the global CMC project team, lead the analytical sub-team across Novartis functions and sites and customers. The position combines strong project management, scientific leadership, and effective customer-facing collaboration. It is an expert role with matrix leadership responsibility.

#LI-Hybrid

Location - Schaftenau, Austria

Temporary position, 2 years. Finishing end of September 2028

Your key responsibilities

• Act as the Analytical Project Lead for assigned biosimilar programs and represent Novartis Analytical Development in the global CMC project team.
• Lead the global, cross-functional analytical sub-team in a matrix setup and align on objectives, priorities, timelines, interfaces and decisions.
• Translate the Statement of Work and agreed customer deliverables into executable analytical plans, milestones, resource requirements and decision points.
• Ensure delivery of analytical work packages by Novartis as the CDMO, in accordance with agreed scope, quality standards, timelines and governance. Proactively manage dependencies, risks, changes and escalation needs.
• Ensure transparent communication of strategy, progress, risks, scientific recommendations and decisions while maintaining clear accountability between customer and CDMO roles.
• Provide scientific and technical oversight of analytical activities performed within Novartis and, where required, at contract laboratories, including analytical method development, validation and transfer, specification setting, release testing and stability programs.
• Lead the preparation and review of high-quality analytical source documents and contributions supporting regulatory submissions, health authority interactions, scientific advice, audits and inspections.
• Be accountable for identifying scientific, technical or GMP issues, and drive robust, science-based solutions and timely decisions.
• Be accountable for analytical resource and budget needs, support financial planning and tracking, and manage delivery within the agreed project framework.
• Communicate project status, priorities, risks, resource needs and recommendations effectively to senior stakeholders and relevant governance bodies.
• Foster a collaborative, accountable and solution-oriented working environment across Novartis Development and external partners.

What you'll bring to the role

• PhD in life sciences, biotechnology, biochemistry, pharmaceutical sciences or a related discipline, with relevant pharmaceutical industry experience, or an equivalent scientific degree with substantial relevant experience.
• Strong experience in biologics CMC development, including experience in analytical development and project leadership particularly in late staged development.
• Demonstrated ability to lead complex, global and cross-functional development projects in a matrix organization without direct authority.
• Broad scientific and technical understanding of analytical development for biologics.
• Project management capabilities, including integrated planning, scope and change management, risk management, resource and budget planning, stakeholder alignment and milestone delivery.
• Good understanding of global regulatory expectations for biologics development and experience contributing to regulatory submissions and health authority interactions.
• Good communication, influencing and stakeholder management skills, with the ability to build effective customer relationships and navigate organizational interfaces.
• Ability to identify critical issues, develop pragmatic solutions, drive decisions and maintain delivery focus in a dynamic environment.
• Proficient scientific and technical writing skills and fluent English, written and spoken.

Rewards :

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 € 65,605.54 EUR/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 sup