Pharmaceutical Analytical Methods Specialist – Validation & Transfer

Novartis; Fatih; On-site; TRY 250,000 - 420,000; Full time

Job summary

Novartis seeks an AS&T Hub team member to execute analytical method development, transfer, validation, and dissolution studies in line with regulatory requirements. The role supports development and marketed products with state-of-the-art analytical methods.

You will stay current with guidelines, ensure compliance of testing monographs, and collaborate across teams to deliver right-first-time results. Strong communication and hands-on analytical chemistry experience are essential.

Qualifications

• BSc or MSc in Chemistry, Pharmacy, Chemical Engineering, or related field.
• 2–4 years 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 with method validation or transfer is a plus.
• Familiarity with regulatory CTD documentation is a plus.
• Ability to work in a fast-paced changing environment
• Team working and customer-oriented mindset
• Good analytical thinking and communication skills
• Proficiency in MS Office; experience with LIMS, Empower, or Minitab is an advantage.
• Good command of English is required

Responsibilities

• Meet Novartis and Health Authority requirements for AS&T.Execute activities per SOPs and lab rules.
• Support AS&T Manager with methods, procedures, and workflows.
• Stay updated with global analytical method development, guidelines, and pharmacopoeial requirements.
• Routinely assess testing monographs and ensure compliance with regulations.
• Evaluate and implement new technologies to maintain state-of-the-art analytical methods.
• Perform analytical method development, transfer, pre-validation, and validation studies, and dissolution analyses.
• Ensure right-first-time execution in analyses and documentation.
• Prepare CTD documents for updated testing monographs.

Skills

Analytical chemistry

HPLC

GC

Dissolution testing

Communication skills

Teamwork

GxP

LIMS/Empower

MS Office

Education

BSc or MSc in Chemistry / Pharmacy

Tools

LIMS

Empower

Minitab

SAP

Job description

Novartis seeks an AS&T Hub team member to execute analytical method development, transfer, validation, and dissolution studies in line with regulatory requirements. The role supports development and marketed products with state-of-the-art analytical methods.

You will stay current with guidelines, ensure compliance of testing monographs, and collaborate across teams to deliver right-first-time results. Strong communication and hands-on analytical chemistry experience are essential.