Assistant Manager - Drug Substance Production (Biopharma)

Biocon Biologics; Johor; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading biopharmaceutical company in Malaysia is seeking an experienced professional to lead upstream production and buffer preparation operations. You will ensure compliance with GMP regulations and support process engineering activities. The ideal candidate should have a degree in a related field, 4-7 years of experience in biopharmaceutical manufacturing, and demonstrate strong leadership and problem-solving skills. A competitive salary and robust benefits package are offered, including medical coverage and opportunities for career advancement.

Benefits

Medical, dental, and insurance coverage

Annual and casual leave

Complimentary duty meals

Access to an in-house gym/sports room

Career advancement opportunities

Qualifications

• 4-7 years of biopharmaceutical manufacturing experience in upstream, buffer preparation, or process engineering.
• Strong understanding of GMP, CQV, deviation management, and validation.
• Experience working cross-functionally in a regulated manufacturing environment.

Responsibilities

• Lead and supervise upstream operations and manage batch performance.
• Oversee buffer preparation operations and ensure compliance.
• Perform facility fit assessments for new product introduction.

Skills

GMP understanding

Problem-solving

Communication

Leadership

Education

Bachelor’s degree in Biotechnology, Chemical/Mechanical Engineering, Pharmacy

Tools

SAP ERP

Job description

Key Responsibilities

Upstream Production

1. Lead and supervise upstream operations including media preparation, seed train expansion, bioreactor operations, and harvest activities.
2. Monitor batch performance, troubleshoot process issues, and drive continuous improvement initiatives.
3. Ensure real-time and accurate documentation in BMRs, logbooks, ECC data, SAP transactions, and batch records.
4. Coordinate with Engineering and Maintenance for equipment readiness, calibration, and preventive maintenance.
5. Manage deviations, change controls, and non-conformances, ensuring timely closure and CAPA implementation.
6. Support execution of validation and qualification activities for upstream equipment and systems.
7. Communicate operational performance, bottlenecks, and resource needs to stakeholders.
8. Provide guidance and training to production associates to strengthen technical and compliance capability.

Buffer Preparation

1. Oversee buffer preparation operations, ensuring OTIF readiness and compliance to support downstream processing.
2. Ensure correct preparation, storage, labeling, and transfer of buffers/media as per production and GMP requirements.
3. Maintain documentation accuracy across BMRs, checklists, log sheets, ECC, and related records for buffer activities.
4. Plan raw material and consumable usage and manage SAP inventory updates to support production schedules.
5. Execute equipment qualification, validation, and commissioning activities for buffer systems.
6. Investigate and manage deviations related to buffer activities and ensure proper documentation and closure.
7. Coordinate with Engineering for calibration, equipment performance, and resolution of equipment issues.
8. Prepare, review, and revise GMP documents, including SOPs, EOPs, BMRs, and log sheets.
9. Train and develop buffer preparation personnel to meet competency and quality standards.

Process Engineering (PE)

1. Perform facility fit assessments for new product introduction and process modifications.
2. Identify production constraints and support debottlenecking strategies to improve throughput and efficiency.
3. Define and apply commissioning and qualification (C&Q) strategies for assigned projects and new installations.
4. Review technical design documents to ensure alignment with GMP, CQV, and system requirements.
5. Support continuous improvement initiatives in process capability, quality, and equipment performance.
6. Support production deviation investigations related to equipment and process failures.
7. Ensure adherence to EHS policies and risk reduction strategies.
8. Standardize and improve upstream/downstream process efficiency including scale-up and engineering support.
9. Collaborate cross-functionally to integrate technical, quality, and operational requirements into project execution.

General

1. Ensure full compliance with GMP, EHS, and regulatory expectations at all times
2. Act as Data Owner for relevant equipment and digital systems ensuring lifecycle and data integrity management
3. Support audit readiness, operational excellence, and continuous improvement culture

Requirements

• Bachelor’s degree in Biotechnology, Chemical/Mechanical Engineering, Pharmacy, or related technical discipline
• 4–7 years biopharmaceutical manufacturing experience in upstream, buffer preparation, or process engineering
• Strong understanding of GMP, CQV, deviation management, validation, and SAP ERP
• Leadership capability with strong communication and problem-solving skills
• Experience working cross-functionally in a regulated manufacturing environment

About The Benefits

At Biocon, you’ll receive a competitive salary and a robust benefits package—medical, dental, and insurance coverage that extends to you and your family. Enjoy annual and casual leave, complimentary duty meals, access to an in-house gym/sports room, and exceptional opportunities for career advancement.