Manufacturing Associate
Job Summary
This temp position is part of a driven team that produces In-Vitro Diagnostic assays via various molecular manufacturing techniques. The activities conducted would be required to comply with industrial and regulatory requirements. The successful candidate will be based in Singapore and report to the manufacturing team.
Duties & Responsibilities
1. Perform activities related to manufacturing products/finished goods to support the manufacturing schedule. These include but are not limited to:
· Bulk Formulation at Microliter (uL) and Milliliter (ml) levels in a laboratory environment
· Tubes / Bottles / Plates dispensing via automated and manual processes.
· Printing and Labeling of products.
2. Ensure daily/monthly production targets are achieved with products manufactured according to established SOPs equipped with knowledge of upstream and downstream processes.
3. Ensure Manufacturing Yield/Defect Rate targets are achieved via proper handling of goods at the raw materials, semi-finished goods, and finished goods level.
4. Participate and collaborate with quality control in root cause analysis activity on non-conforming incidents. Implement corrective and preventive action.
5. Inventory control of reagents and supplies.
6. Author reports / documentation where necessary.
7. Participate in method transfer and process validation.
8. Collaborate with cross-functional teams (e.g. Quality, R&D, Supply Chain, and Quality Assurance) on product transfer projects.
Job Requirements & Attributes
• Diploma in Life Sciences (Biotechnology, Biomedical Science, Biochemistry, Life Science or related).
• 0-6 years of hands-on experience in Bioprocess manufacturing and Biomedical device manufacturing setting, experience in IVD field (e.g. real-time PCR or NGS) is a plus.
• Some of the working knowledge in handling direct and indirect manufacturing documents is desirable. These include but are not limited to:
· Manufacturing Work Instructions (MWI)
· Manufacturing Batch Records
· General work instructions that incorporate safety and CGMP practices.
• Knowledge in areas related to ISO9001, ISO13485, Good Manufacturing Practices (GMP), Good Laboratory (GLP) or other international standards is desirable.
• Some of the working knowledge of an ERP system (SAP) and document control software is an asset.
• Some organizational skills, able to multi-task and meticulous to details.
• Good communication skills and commitment to teamwork.
• Willing to learn new things in a fast-growing company and work environment.
• High level of integrity and dependability with a strong sense of urgency and results delivery, willing to put extra effort into driving the process and achieving the goal.
This is a temporary, part-time position.
Job Summary
This temp position is part of a driven team that produces In-Vitro Diagnostic assays via various molecular manufacturing techniques. The activities conducted would be required to comply with industrial and regulatory requirements. The successful candidate will be based in Singapore and report to the manufacturing team.
Duties & Responsibilities
1. Perform activities related to manufacturing products/finished goods to support the manufacturing schedule. These include but are not limited to:
· Bulk Formulation at Microliter (uL) and Milliliter (ml) levels in a laboratory environment
· Tubes / Bottles / Plates dispensing via automated and manual processes.
· Printing and Labeling of products.
2. Ensure daily/monthly production targets are achieved with products manufactured according to established SOPs equipped with knowledge of upstream and downstream processes.
3. Ensure Manufacturing Yield/Defect Rate targets are achieved via proper handling of goods at the raw materials, semi-finished goods, and finished goods level.
4. Participate and collaborate with quality control in root cause analysis activity on non-conforming incidents. Implement corrective and preventive action.
5. Inventory control of reagents and supplies.
6. Author reports / documentation where necessary.
7. Participate in method transfer and process validation.
8. Collaborate with cross-functional teams (e.g. Quality, R&D, Supply Chain, and Quality Assurance) on product transfer projects.
Job Requirements & Attributes
• Diploma in Life Sciences (Biotechnology, Biomedical Science, Biochemistry, Life Science or related).
• 0-6 years of hands-on experience in Bioprocess manufacturing and Biomedical device manufacturing setting, experience in IVD field (e.g. real-time PCR or NGS) is a plus.
• Some of the working knowledge in handling direct and indirect manufacturing documents is desirable. These include but are not limited to:
· Manufacturing Work Instructions (MWI)
· Manufacturing Batch Records
· General work instructions that incorporate safety and CGMP practices.
• Knowledge in areas related to ISO9001, ISO13485, Good Manufacturing Practices (GMP), Good Laboratory (GLP) or other international standards is desirable.
• Some of the working knowledge of an ERP system (SAP) and document control software is an asset.
• Some organizational skills, able to multi-task and meticulous to details.
• Good communication skills and commitment to teamwork.
• Willing to learn new things in a fast-growing company and work environment.
• High level of integrity and dependability with a strong sense of urgency and results delivery, willing to put extra effort into driving the process and achieving the goal.
This is a temporary, part-time position.