Executive, Analytical (Pharmaceutical R&D)

Duopharma Biotech Bhd Group of Companies.; Shah Alam; On-site; MYR 72,000 - 110,000; Full time

Job summary

Duopharma Innovation Sdn. Bhd. is seeking an Executive, Analytical to join the Analytical Department in Glenmarie, Selangor.

The role focuses on developing and validating analytical methods, conducting stability studies, and supporting pharmaceutical product development under GLP and ISO/IEC 17025 standards. You will collaborate with Formulation, Quality Management, Production, and Quality Control teams to ensure reliable testing, cross-functional support during scale-up, and timely regulatory

Qualifications

• Bachelor's Degree in Science or a related discipline.
• Minimum 3 years of experience in pharmaceutical or related industry.
• Experience in analytical laboratory operations or similar capacity.

Responsibilities

• Develop and validate analytical methods for raw materials, active ingredients, intermediates, and finished products.
• Perform analytical testing using HPLC, GC, MS, ICP-OES, and other instruments.
• Conduct stability study testing for R&D batches.
• Support product development, technology transfer, and regulatory submissions.
• Prepare and maintain analytical documentation (Lab notebooks, development reports, SOPs).

Skills

Analytical method development

GLP

Regulatory knowledge

Teamwork & communication

Education

Bachelor's degree in Science or related

Tools

HPLC

GC

MS

ICP-OES

Dissolution Testing

UV-Vis Spectrophotometer

Job description

Executive, Analytical (Pharmaceutical R&D)

Location: Glenmarie, Selangor
Company: Duopharma Innovation Sdn. Bhd.

Job Summary

We are looking for a technically competent and detail-oriented Executive, Analytical to join our Analytical Department. This role is responsible for developing and validating analytical methods, conducting stability studies, supporting pharmaceutical product development, and maintaining analytical laboratory operations in compliance with Good Laboratory Practice (GLP) and MS ISO/IEC 17025 requirements.

You will work closely with Formulation, Quality Management, Production, and Quality Control teams to support product development, technology transfer, product scale-up, and regulatory submissions.

Key Responsibilities

Analytical Method Development & Validation

Develop and validate suitable, specific, precise, and accurate analytical methods for raw materials, active ingredients, intermediates, and finished products.

Perform analytical testing using laboratory instruments such as HPLC, GC, Mass Spectrometry (MS), ICP, AAS, and other relevant equipment.

Conduct stability study testing for Research & Development (R&D) batches.

Support analytical investigations, troubleshooting, and problem-solving to ensure accurate and reliable testing results.

Product Development & Cross-Functional Support

Work closely with the Formulation team to support product development projects and formulation trials through analytical testing.

Provide analytical information and technical support to Quality Management, Production, and Quality Control teams during product scale-up.

Troubleshoot analytical issues and recommend appropriate precautionary measures during testing activities.

Support new product dossier registration and respond to regulatory queries within agreed timelines.

Technical Documentation & Regulatory Compliance

Prepare and maintain analytical documentation, including:

Laboratory notebooks (OneNote).

Analytical Development Reports.

Analytical Test Methods and Specifications.

Raw Material Evaluation Reports.

Stability Study Reports.

Standard Operating Procedures (SOPs).

Ensure laboratory activities comply with Good Laboratory Practice (GLP), MS ISO/IEC 17025, and the Duopharma Innovation Quality Manual.

Participate in ISO/IEC 17025-related activities and maintain appropriate laboratory documentation.

Laboratory & Equipment Management

Perform preventive maintenance and calibration of laboratory equipment according to established schedules.

Monitor laboratory equipment performance and ensure equipment remains in suitable working condition.

Manage laboratory inventory, chemicals, and operating supplies.

Maintain laboratory cleanliness, organisation, and safety standards.

Requirements

Qualifications

Bachelor's Degree in Science or a related discipline.

Higher qualifications in a relevant scientific field will be an added advantage.

Experience

Minimum 3 years of working experience in the pharmaceutical or related industry.

Experience in analytical laboratory operations or a similar capacity is required.

Technical Skills & Knowledge

Extensive knowledge of laboratory analysis and analytical method development.

Familiarity with pharmaceutical requirements and new product registration processes.

Hands-on experience operating analytical instruments, including:

High Performance Liquid Chromatography (HPLC-UV and HPLC-PDA).

Gas Chromatography (GC).

Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES).

Dissolution Testing Equipment.

UV-Visible Spectrophotometer.

Familiarity with NPRA, FDA, ICH, ASEAN, EMEA, GLP, and WHO requirements.

Proficient in Microsoft Office applications, particularly Word, Excel, and PowerPoint.

Strong analytical, research, and problem-solving abilities.

Excellent teamwork, leadership, and communication skills.

Ability to develop practical solutions to technical and workplace challenges.

Sound decision-making skills, even when information is limited or unclear.

Ability to work independently and manage multiple priorities.

Strong time management and organisational skills.

Adaptable, proactive, and willing to learn new technologies and techniques.

Why Join Us?

Gain exposure to pharmaceutical analytical method development and validation.

Work with advanced analytical laboratory instruments and technologies.

Participate in new product development, stability studies, and regulatory submission activities.

Collaborate with Formulation, Quality Management, Production, and Quality Control teams.

Develop your technical expertise within a pharmaceutical R&D environment.

Duopharma Biotech Berhad began with the establishment of Duopharma (M) Sdn Bhd in 1978. Incorporated in 2000, we are one of Malaysia’s leading pharmaceutical companies listed on the Bursa Malaysia’s Main Market. We specialise in manufacturing, R&D, and marketing of generic drugs and consumer healthcare products (CHAMPS®, FLAVETTES® & UPHAMOL) as well as biosimilars (ERYSAA®, Basalog One®). As a pioneer in halal pharmaceuticals, we were the 1st to receive JAKIM certification for OTC and prescription products under MS2424:2019. Headquartered in Kuala Lumpur, we operate three GMP-certified plants (Klang, Bangi & Glenmarie) and have a growing presence in Indonesia, the Philippines and Singapore.

Duopharma Biotech Berhad began with the establishment of Duopharma (M) Sdn Bhd in 1978. Incorporated in 2000, we are one of Malaysia’s leading pharmaceutical companies listed on the Bursa Malaysia’s Main Market. We specialise in manufacturing, R&D, and marketing of generic drugs and consumer healthcare products (CHAMPS®, FLAVETTES® & UPHAMOL) as well as biosimilars (ERYSAA®, Basalog One®). As a pioneer in halal pharmaceuticals, we were the 1st to receive JAKIM certification for OTC and prescription products under MS2424:2019. Headquartered in Kuala Lumpur, we operate three GMP-certified plants (Klang, Bangi & Glenmarie) and have a growing presence in Indonesia, the Philippines and Singapore.