The AS&T Team Lead is responsible for managing the Analytical Science & Technology function, providing scientific and technical leadership for analytical method development, validation, transfer, and lifecycle management. This role ensures analytical excellence in support of product development, commercial manufacturing, and regulatory compliance while leading a high-performing team and collaborating cross-functionally across the organization.
Job Description
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
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