AS&T Hub Specialist

Novartis; Pendik; On-site; TRY 350,000 - 480,000; Full time

Job summary

Novartis is seeking an AS&T Hub team member in Turkey to execute analytical method development, transfers, validations, and comparative dissolution studies. You will ensure testing monographs comply with current regulations, pharmacopeias, and internal quality standards while supporting development and marketed products with state-of-the-art analytics.

The ideal candidate has strong analytical chemistry expertise, good problem-solving and communication skills, and a track record of

Qualifications

• BSc or MSc degree in Chemistry, Pharmacy, Chemical Engineering or related field.
• 2–4 years of experience in analytical/QC lab, preferably pharma.
• Hands-on with HPLC, GC, TLC/HPTLC, UV and dissolution testing.
• Knowledge of cGMP & cGLP and basic SAP.
• Experience in analytical method validation and/or method transfer.
• Familiarity with CTD documentation in regulatory submissions.
• Proficient in MS Office; LIMS/Empower/Minitab is a plus.
• Good command of English.

Responsibilities

• Ensure compliance with Novartis and Health Authority requirements.
• Execute activities per SOPs and laboratory rules.
• Stay updated with guidelines, pharmacopeial requirements, and methods.
• Perform analytical method development, transfer, pre-validation and validation.
• Prepare CTD documents for updated testing monographs.

Skills

HPLC

GC

TLC/HPTLC

UV

Dissolution testing

cGMP & cGLP

SAP basics

Method validation

Method transfer

CTD docs

LIMS

Empower

Minitab

MS Office

English

Education

BSc or MSc in Chemistry, Pharmacy, Chemical Engineering

Tools

LIMS

Empower

Minitab

Job description

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.

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)