Pharmaceutical Chemist

Westrama Management S; Singapore; Sur place; SGD 90 000 - 120 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

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

Formation

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

Outils

Waters Empower

Agilent OpenLab

LIMS

Description du poste

Job Description of Pharmaceutical Chemist

Key Roles & Responsibilities

1.Analytical Testing & Method Development

• Perform complex chemical and physical analyses of active pharmaceutical ingredients (APIs), excipients, in-process materials, and finished drug products using advanced analytical instrumentation (including HPLC, UHPLC, GC, UV-Vis, FTIR, Dissolution, and Karl Fischer titration).
• Develop, optimize, and validate new analytical methods in strict accordance with ICH Q2 (R1/R2) guidelines and pharmacopeial standards (USP, EP, BP, JP).
• Execute method transfers between R&D, contract manufacturing organizations (CMOs), and Quality Control (QC) laboratories.

2.Formulation Support & Stability Studies

• Collaborate with the formulation and process development teams to evaluate the chemical compatibility of excipients and APIs during pre-formulation and scale-up phases.
• Design, manage, and execute stability testing programs (accelerated, intermediate, and long-term) in compliance with ICH Q1A–Q1E guidelines to establish product shelf-life and storage conditions.
• Analyze stability data trends and author comprehensive technical stability reports for regulatory submissions.

3.Quality Assurance, cGMP & Regulatory Compliance

• Ensure all laboratory testing, documentation, and data recording strictly adhere to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and ALCOA+ data integrity principles.
• Lead technical investigations into Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviation events; perform root-cause analysis (RCA) and implement effective Corrective and Preventive Actions (CAPA).
• Prepare and review Standard Operating Procedures (SOPs), analytical test protocols, Specifications, and Certificates of Analysis (CoA).
• Support internal quality audits and external regulatory inspections by the Singapore Health Sciences Authority (HSA), US FDA, EMA, and PIC/S authorities.

4.Laboratory Management & Mentorship

Over see the routine calibration, qualification (IQ/OQ/PQ), and preventive maintenance of analytical laboratory instruments, troubleshooting hardware and software issues to minimize downtime.

• Manage laboratory inventory, reference standards, reagents, and chemical waste disposal in compliance with Singapore National Environment Agency (NEA) and Workplace Safety and Health (WSH) regulations.
• Provide technical guidance, training, and mentorship to junior chemists and laboratory technicians to maintain high analytical standards and operational efficiency.

Job Requirements & Qualifications

• Education: Bachelor’s Degree, or master’s degree, in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, Medicinal Chemistry, or a closely related scientific discipline from a recognized institution.
• Experience: Minimum of 6 years of relevant hands‑on experience in a pharmaceutical, biopharmaceutical, or GMP-regulated analytical/formulation laboratory environment.
• Technical Expertise:

• Demonstrated proficiency in operating and troubleshooting chromatographic and spectroscopic instruments (e.g., HPLC, GC, FTIR, UV-Vis) and Chromatography Data Systems (e.g., Waters Empower, Agilent Open Lab).

• Strong working knowledge of analytical method development, validation, and pharmacopeial compendia (USP/EP/BP).
• Proven track record in managing OOS/OOT investigations, root‑cause analysis, and CAPA implementation within a Quality Management System (QMS).
• Regulatory Knowledge: Thorough understanding of cGMP, GLP, ICH guidelines, PIC/S standards, and local HSA regulatory requirements.
• Core Competencies:
• Strong analytical and critical‑thinking skills with meticulous attention to detail and data integrity.
• Ability to author clear, concise technical protocols, validation reports, and regulatory documentation.
• Effective interpersonal and communication skills to collaborate across cross‑functional teams (Quality Assurance, Regulatory Affairs, Production, and R&D).