Manufacturing Specialist

This position is part of a driven team that performsIn-Vitro Diagnostics Assay production via various molecular manufacturing techniques. Activitiesconducted would be required to comply with industrial and regulatory requirements.

The successful candidate will be based in Singapore and reports to the manufacturing team.

Duties &Responsibilities

1. Perform activities related to manufacturing of products/finished goods to support manufacturing schedule. These include but 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, Labeling, Kit Assembling and Packing 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 material, semi-finished goods and finished goods level.

4. Ensure batch records are maintained according to ISO standards.

5. Ensure daily maintenance work in Manufacturing floor, including waste disposal, equipment maintenance, and cleanliness maintenance are completed.

6. Participate and collaborate with quality in root cause analysis activity on non-conforming incident/excursion. Recommend and implement corrective and preventive action.

7. Involved in quality and safety risk assessment, audits, biosafety, emergency response, and TMS.

8. Inventory control of reagents and supplies/consumables via ERP and non-ERP systems. Monitor consumables level and active ordering.

9. Author deviations, reports, and documentations where necessary.

10. Perform qualification and technical selection of manufacturing equipment (IOPQ). Involve in method transfer and process validation.

11. Perform inspection on in-process materials.

12. Act as a mentor and OJT trainer, provide guidance to junior staff.

13. Collaborate with cross-functional team (e.g. Quality, PT, R&D, Supply Chain) on product transfer and process improvement projects.

14. Author and improve MWI and MFM.

15. Other duties as assigned.

JobRequirements & Attributes

• Bachelor’s Degree in Life Sciences or related. Diploma/Higher NITEC with at least 5 years of relevant experience will be considered.

• At least 3 years of hands on experience in Bioprocess/Biomedical device manufacturing, experience in IVD field is a plus.

• Good working knowledge in handling of direct and indirect manufacturing documents. These include but not limited to:

· Manufacturing Work Instructions (MWI)

· Manufacturing Batch Records

· General work instructions that incorporate safety and cGMP practices.

• Knowledge in areas related to ISO13485 and cGMP is an advantage.

• Working knowledge of an ERP system (SAP) and document control software is preferred.

• Strong organizational skills, ability to multi-task with aggressive timelines and strong attention to detail; strong interpersonal and team skills, ability to communicate well.

• Strong problem-solving skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses; strong desire to learn, adapt and advance in a fast-growing environment.

• High level of integrity and dependability with a strong sense of urgency and results delivery, willing to put extra effort to drive the process and achieve goal.