AS&T Hub Specialist
Novartis · Pendik
Job description
About the role
The AS&T Hub Specialist joins Novartis' Analytical Sciences & Technology team to drive analytical method development, transfer, validation and comparative dissolution studies. You will ensure that all testing monographs and analytical activities comply with Novartis standards, health‑authority regulations and current pharmacopeial requirements.
Key responsibilities
- Execute analytical method development, method transfer, pre‑validation, validation and comparative dissolution projects in line with SOPs and cGMP/cGLP guidelines.
- Maintain up‑to‑date knowledge of global analytical guidelines, pharmacopeial standards and emerging technologies.
- Assess testing monographs regularly and proactively ensure compliance with official regulations, QM, GOP and internal SOPs.
- Prepare CTD documentation for updated testing monographs and support regulatory submissions.
- Deliver right‑first‑time results in all analyses and associated documentation.
Required profile
- BSc or MSc in Chemistry, Pharmacy, Chemical Engineering or related field.
- 2–4 years of experience in an analytical/QC laboratory, preferably within the pharmaceutical industry.
- Hands‑on experience with HPLC, GC, TLC/HPTLC, UV spectroscopy and dissolution testing.
- Familiarity with cGMP, cGLP, SAP and regulatory documentation (CTD, testing monographs).
- Strong analytical thinking, communication skills and ability to work in a fast‑changing environment.
Required skills
- HPLC
- GC
- TLC/HPTLC
- UV spectroscopy
- Dissolution testing
- Analytical method validation
- Method transfer
- cGMP / cGLP
- SAP
- CTD documentation
- MS Office
- LIMS
- Empower
- Minitab
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Published 1 month ago
Expires 1 week from now
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Novartis
Pendik