Senior Pharmaceutical Chemist - Analytical & GMP Lead

Westrama Management S; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

We are seeking a Pharmaceutical Chemist to conduct advanced analytical testing of APIs, excipients, and finished drug products, and to develop, validate, and transfer methods per ICH and pharmacopeial standards. The role includes leading investigations into OOS/OOT, CAPA, and maintaining cGMP/GLP data integrity within a QMS.

You will support formulation development, stability studies, and regulatory documentation, while mentoring junior staff and ensuring adherence to SOPs and quality systems.

Qualifications

• Bachelor’s or master’s degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, Medicinal Chemistry, or related field.
• Minimum 6 years of hands-on pharmaceutical analytical/formulation lab experience.
• Proficiency with HPLC, GC, FTIR, UV-Vis and chromatography software.
• Experience with OOS/OOT investigations and CAPA within a QMS.
• Regulatory knowledge of cGMP, GLP, ICH, PIC/S, and local HSA requirements.

Responsibilities

• Perform complex analyses of APIs, excipients, in-process materials, and finished products using HPLC, UHPLC, GC, UV-Vis, FTIR, Dissolution and Karl Fischer.
• Develop, validate, and transfer analytical methods per ICH Q2 and pharmacopeial standards (USP/EP/BP/JP).
• Lead method transfers between R&D, CMOs and QC laboratories.
• Collaborate on formulation and stability studies to assess excipe nt/API compatibility and establish shelf-life.
• Lead investigations into OOS/OOT, root-cause analysis, and CAPA within a QMS.
• Prepare and review SOPs, test protocols, specifications, and CoA; support audits and regulatory inspections.

Skills

Analytical testing

Method development

HPLC

GC

UV-Vis

FTIR

Dissolution

Karl Fischer

ICH guidelines

cGMP

GLP

CAPA

OOS/OOT investigations

SOPs

CoA

QMS

HSA/FDA/PIC/S regulatory knowledge

Education

Bachelor’s or Master’s in Chemistry/Analytical Chemistry

Tools

Waters Empower

Agilent OpenLab

LIMS

Job description

We are seeking a Pharmaceutical Chemist to conduct advanced analytical testing of APIs, excipients, and finished drug products, and to develop, validate, and transfer methods per ICH and pharmacopeial standards. The role includes leading investigations into OOS/OOT, CAPA, and maintaining cGMP/GLP data integrity within a QMS.

You will support formulation development, stability studies, and regulatory documentation, while mentoring junior staff and ensuring adherence to SOPs and quality systems.