Summary
About the Role
Major Responsibilities:
- Lead the development, optimization, validation, transfer, and lifecycle management of analytical methods for raw materials, intermediates, and finished products.
- Serve as a Subject Matter Expert in analytical techniques such as HPLC, UPLC, GC, spectroscopy, dissolution, and physicochemical testing.
- Provide scientific and technical guidance for troubleshooting analytical issues, OOS results, deviations, investigations, and method performance challenges.
- Ensure analytical methods are robust, fit for purpose, and compliant with applicable GMP, ICH, FDA, EMA, and internal quality requirements.
- Lead, coach, and develop a team of analysts and scientists by setting clear objectives, managing performance, and supporting professional growth.
- Collaborate with Manufacturing, Quality Control, Quality Assurance, R&D, Regulatory Affairs, and other stakeholders to support product development, technology transfer, and commercial operations.
- Review and approve analytical documentation, including protocols, reports, specifications, SOPs, investigations, and regulatory submission content.
- Drive continuous improvement initiatives, laboratory efficiency, CAPA effectiveness, data integrity, digitalization, and key performance indicator performance.
Obligatory Requirements:
- Bachelor’s, Master’s, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- 3+ years of experience in analytical sciences within the pharmaceutical, biotechnology, or related regulated industry.
- Proven experience in analytical method development, validation, transfer, troubleshooting, and lifecycle management.
- Strong technical knowledge of analytical techniques such as HPLC, UPLC, GC, dissolution, spectroscopy, and physicochemical testing.
- Good understanding of GMP, ALCOA+ data integrity principles, ICH Q2, ICH Q14, and relevant FDA, EMA, and regulatory expectations.
- Experience with laboratory systems such as LIMS, Empower, Chromeleon, and computerized systems in a regulated environment.
- Previous leadership, supervisory, or people management experience is strongly preferred.
- Strong communication, stakeholder management, problem-solving, prioritization, and team leadership skills
- Fluency in Romanian and English language.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
