Officer - Biosimilar (Biotechnology, Bioprocess engineering @ Biochemistry)

Ain Medicare Sdn Bhd; Kota Bharu; On-site; MYR 60,000 - 90,000; Full time

Job summary

AIN MEDICARE SDN. BHD. in Malaysia is seeking a dedicated professional to support biosimilar product development, manufacturing, and process improvement within GMP-compliant systems.

The role involves preparing technical documentation, coordinating with cross-functional teams, and monitoring process performance to ensure quality timelines. The ideal candidate holds a Bachelor's degree in Biotechnology or related fields and has 2–5 years' experience in pharma/biotech.

Qualifications

• Bachelor's degree in biotechnology or related field.
• 2–5 years of pharma/biotech/biosimilar experience.
• Knowledge of GMP, regulatory requirements, quality systems.
• Strong analytical, documentation, communication, and problem-solving abilities.

Responsibilities

• Support biosimilar product development, manufacturing, and process improvement activities
• Support quality activities in GMP/regulatory compliance
• Prepare and maintain technical documentation
• Coordinate with cross-functional teams
• Monitor process and product performance
• Support investigations and CAPA; ensure timelines

Skills

Analytical skills

Documentation

Communication skills

Problem-solving

Education

Bachelor's Degree in Biotechnology, Biochemistry, Bioprocess Engineering, Microbiology, or a related field

Job description

Responsible for supporting biosimilar product development, manufacturing, process improvement, and/or quality activities in compliance with GMP and applicable regulatory requirements. The role includes preparing and maintaining technical documentation, coordinating with cross-functional teams, monitoring process and product performance, supporting investigations and CAPA, and ensuring activities are completed according to approved procedures, quality standards, and timelines.

Key responsibilities

Support biosimilar product development, manufacturing, and process improvement activities

Support quality activities in compliance with GMP and applicable regulatory requirements

Prepare and maintain technical documentation

Coordinate with cross-functional teams

Monitor process and product performance

Support investigations and CAPA

Ensure activities are completed according to approved procedures, quality standards, and timelines

About you

Bachelor's Degree in Biotechnology, Biochemistry, Bioprocess Engineering, Microbiology, or a related field

Preferably 2–5 years of experience in the pharmaceutical, biotechnology, or biosimilar industry

Knowledge of GMP, regulatory requirements, quality systems, and pharmaceutical manufacturing processes

Good analytical, documentation, communication, and problem-solving skills

Established in 1993 in Malaysia, AIN MEDICARE SDN. BHD. is a trusted name and leading manufacturer of pharmaceutical products ranging from Large Volume Parenterals, Small Volume Parenterals, Irrigation Solutions, Haemodialysis concentrates and Peritoneal Dialysis solutions.

A wholly-Malaysian owned company located in Kelantan, on the East Coast of Peninsular Malaysia, WE operates from a multi-million dollar state-of-the art pharmaceutical complex fully equiped with production floor, microbiological and chemical laboratories, warehouse and administrative center.

Established in 1993 in Malaysia, AIN MEDICARE SDN. BHD. is a trusted name and leading manufacturer of pharmaceutical products ranging from Large Volume Parenterals, Small Volume Parenterals, Irrigation Solutions, Haemodialysis concentrates and Peritoneal Dialysis solutions.

A wholly-Malaysian owned company located in Kelantan, on the East Coast of Peninsular Malaysia, WE operates from a multi-million dollar state-of-the art pharmaceutical complex fully equiped with production floor, microbiological and chemical laboratories, warehouse and administrative center.