AS&T Hub Specialist
Skills
About the role
Summary
The AS&T Hub (Analytical Sciences & Technology) team member is responsible for executing analytical method development, method transfer, validation, and comparative dissolution studies in compliance with Novartis and Health Authority requirements. This role ensures the ongoing compliance of testing monographs and analytical activities with current regulations, pharmacopeias, and internal quality standards, while supporting both development and marketed products with state-of-the-art analytical methods. The ideal candidate combines strong technical expertise in analytical chemistry with excellent communication and problem-solving skills, contributing to right-first-time execution across all laboratory activities.
About the Role
Major Accountabilities:
Ensure that Novartis and Health Authority requirements concerning the AS&T Department are fully met.
Execute the main activities in accordance with established SOPs and laboratory rules.
Fulfill responsibilities assigned by the AS&T Manager accurately and in a timely manner, in conformance with methods, procedures, and workflows.
Stay up to date with global analytical method development studies, current guidelines, and pharmacopeial requirements.
Routinely assess testing monographs and proactively ensure compliance of all activities with current official regulations, pharmacopeias, QM, GOP, and SOPs.
Evaluate and implement new technologies required to maintain state-of-the-art analytical methods for both development and marketed products.
Execute analytical method development, method transfer, pre-validation and validation studies, and comparative dissolution analyses.
Ensure right-first-time execution in all analyses and documentation.
Prepare the related CTD documents for updated testing monographs.
Minimum Requirements
BSc or MSc degree in Chemistry, Pharmacy, Chemical Engineering, or a related field.
Minimum 2-4 years of experience in an analytical/QC laboratory, preferably within the pharmaceutical industry.
Hands-on experience with analytical techniques such as HPLC, GC, TLC/HPTLC, UV and dissolution testing.
Knowledge of cGMP& cGLP and basic SAP
Experience in analytical method validation and/or method transfer activities is an asset.
Familiarity with regulatory documentation (e.g., CTD sections, testing monographs) is a plus.
Ability to work in a fast-paced changing environment
Team working and customer-oriented mindset
Good analytical thinking skills
Strong interpersonal written and verbal communication skills
Proficiency in MS Office; experience with LIMS, Empower, or Minitab is an advantage.
Good command of English is required
Work Experience
Sound technical & scientific knowledge of pharmaceutical/ chemical
analytics/QC/R&D/ equivalent.
Skills
Communication Skills.
Continuous Learning.
Dealing With Ambiguity.
Decision Making Skills.
Gxp.
Industry Standards.
Laboratory Equipment.
Laboratory Excellence.
Self-Awareness.
Technological Expertise.
Total Quality Management.
Languages
English.
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)
Division
Operations
Business Unit
Quality
Location
Türkiye
Site
İstanbul Kurtköy
Company / Legal Entity
TR01 (FCRS = TR001) Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.
Functional Area
Quality
Job Type
Full time
Employment Type
Temporary (Fixed Term)
Shift Work
No
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