Biopharmaceutical Production Associate – Drug Substance

Biocon; Gelang Patah; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Biopharmaceutical Production Associate to support the end-to-end manufacturing operations within the Drug Substance department. The role involves ensuring GMP compliance, managing production schedules, and leading investigations into process deviations. Candidates must hold a relevant degree and have 2 - 4 years of experience in biopharmaceutical manufacturing, with solid knowledge of process operations and documentation practices. Competitive salary and robust benefits package offered, including medical coverage and career advancement opportunities.

Benefits

Medical coverage

Dental coverage

In-house gym/sportsroom

Career advancement opportunities

Qualifications

• Bachelor’s Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent.
• 2 - 4 years of hands-on experience in Drug Substance manufacturing or related process operations.
• Strong understanding of GMP, process operations, and cleanroom practices.
• Excellent understanding of Good Documentation Practices (GDP) and ALCOA+ principles.

Responsibilities

• Monitor and ensure compliance with GMP requirements.
• Ensure batches are manufactured as per the approved production plan.
• Manage production planning and inventory control.
• Lead investigation of deviations and implement CAPA.
• Support training and competency evaluation of production personnel.

Skills

GMP compliance

Production planning

Deviation investigation

SAP operation

Biopharmaceutical processes

Education

Bachelor’s Degree in Biotechnology

Bachelor’s Degree in Chemical Engineering

Bachelor’s Degree in Bioprocess Engineering

Bachelor’s Degree in Biochemistry

Tools

SAP

Process equipment

Job description

Biopharmaceutical Production Associate – Drug Substance

The Associate is responsible for supporting the end-to-end manufacturing operations within the Drug Substance (DS) department — ensuring compliance with Good Manufacturing Practices (GMP), timely execution of production batches, effective documentation, equipment qualification, and adherence to EHS and quality standards. The role contributes directly to achieving high process robustness, consistent batch performance, and continuous improvement in production efficiency and quality.

Job Responsibilities

Monitor and ensure compliance with GMP requirements across all Drug Substance operations.

Ensure batches are manufactured as per the approved production plan without delays.

Ensure strict adherence to SOPs and that the team follows defined procedures.

Manage production planning and inventory control to ensure timely availability of raw materials prior to batch start.

Coordinate DS dispensing activities with the team and ensure timely release of batches.

Review and submit all GMP documentation to QA in accordance with established SLAs.

Lead or support investigation of deviations, OOS, OOT, and non-conformances, implement CAPA, and ensure timely closure as per SLA.

Ensure all production equipment remains in qualified status in coordination with cross-functional teams (CFT).

Coordinate preventive and breakdown maintenance of equipment with Engineering and Maintenance.

Participate in CAPEX and OPEX planning for the department.

Initiate, coordinate and verify CAPA actions arising from internal or external audit observations.

Guide team members in maintaining risk and hazard assessments, aspect/impact registers, and ensure adequacy of control measures.

Follow and promote EHS procedures, ensuring full implementation of the EHS management system; review progress of EHS objectives periodically.

Assign and monitor performance objectives for production personnel to ensure optimal manpower utilization.

Support training and competency evaluation of production personnel to minimize manual or procedural errors.

Ensure smooth execution of commercial, clinical, and developmental campaigns in compliance with Quality and Safety standards.

Drive continuous improvement initiatives within team functions, skills, and employee engagement.

Support process lifecycle management through validation cycles and ongoing improvements for consistent process robustness.

Take active part in Downstream Purification (DSP-1, DSP-2) and Buffer Preparation Area operations as required.

Ensure adequate personnel availability and scheduling for all planned activities.

Ensure On-Time-In-Full (OTIF) execution of all downstream and buffer preparation activities per production plan.

Develop basic SAP operation capability and ensure accurate entries for production activities.

Requirements

Bachelor’s Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent field.

2 - 4 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations (Downstream, Upstream, or Buffer Preparation).

Strong understanding of GMP, process operations, and cleanroom practices.

Prior exposure to audits, deviations, CAPA handling, and EHS systems preferred.

Working knowledge of process equipment (tanks, filtration skids, chromatography, UF/DF systems).

Familiarity with batch records, electronic documentation, and SAP transactions.

Excellent understanding of Good Documentation Practices (GDP) and ALCOA+ principles.

Benefits

AtBiocon,you’llreceiveacompetitivesalaryandarobustbenefitspackage—medical,dental,andinsurancecoveragethatextendstoyouandyourfamily.Enjoyannualandcasualleave,complimentarydutymeals,accesstoanin-housegym/sportsroom,andexceptionalopportunitiesforcareeradvancement.