Pharmaceutical Chemist

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).