- New startup Contract Development and Manufacturing Organization (CDMO).
- First product, RV (Retrovirus) , was in development from Media preparation, Pooling to Bulk filing and was ready for engineering run.
- Involved in designing and setting up of the GMP production suite and acquiring equipment such as Mixer tank, Autoclave, FIT, Isolator, etc.
- Drafted and completed equipment URS, IQ/OQ/PQ, SOP, SCS (System Configuration Specification) documentation.
- Working with various stakeholders to design the production flow.
- Procuring materials for the product such as In-process filters, designing single-use connections and bags (working with various vendors).
- Developed operations training materials for Biotechnicians.
- Developed Inventory management application (Tulip Software) with consultants. Tulip is a cloud-based application platform for building manufacturing applications.

•- Manufacture of Vaccine (against pneumococcal disease) up to Bulk filing (final formulation and product packing will be completed in oversea)
- 10 serotypes of pneumococcus which are conjugated to a carrier protein.
- Main process steps includes:
1) Fermentation of bacterial strains, followed by inactivation and purification of polysaccharides (PS).
Inoculation -> Fermentor -> Inactivation -> Purification (Ultrafiltration, column chromatography) -> Precipitation -> Drying (powder form).
2) Fermentation of E. coli for the production of protein D (PD), followed by
PD purification.
Preculture in medium -> Culture in Fermentor -> Homogenization -> Purification with chromatographic steps and disfiltration -> Sterile filtration (liquid form).
3) Production of conjugates for coupling of each of the PS to PD.
Microfludisation -> Conjugation with chemical reagent -> Purification by chromatography -> Sterile filtration
- People management skills and managed team up to 15 Biotechnicians or Operators.
- Knowledge in aseptic manipulation.
- Participated in process validation with global technical team.
- Drafted documentation such as PQ, SOP.
- Developed CAPA for deviations.
- EHS Safety committee, closed CAPA from safety inspection/GEMBA.
- Development, coaching/mentoring of N-1.
- Maximising output of manufacturing processes through Kaizens improvement.
- Operational material planner to ensure seamless execution of various processing steps.
- Handled GSK internal customers and global network team for user requirements for projects.
- Understand stakeholder requirements and needs to manage and accomplish internal site projects.
- Audit ready for operational and material topics

• Direct and supervise a team of production technicians and assistants in the operations of packaging for both cans and pouches.
• Provide the team with positive working environment and motivation. Understand their individual aspiration, obviate grievance and build up collaboration and cohesive as a team.
• Provide strong, effective first-line management to ensure efficient and timely execution of the production schedule and meet yield target, achieving and maintaining targeted output.
• Ensure production schedules are follow closely to achieve the targeted yearly capacity for market requirement.
• Maintain a clean and excellent workplace to reduce any hygiene related issues or microbial contamination.
• Ensure good manufacturing practices and documentation that adhere to corporate and government regulatory agencies' requirements
• Ensure continuous compliance to Good Manufacturing Procedures (cGMP) in designated areas of responsibilities
• Maintaining a safe working environment by improving safety awareness and safety culture through safety topic talk and encourage feedback from staffs and contributed to zero EHS incident or case.
• Resolve packaging quality issues, ensure correction action plans are initiated and monitored, competent in writing deviation reports. Supported in writing presentation materials, poster presentation.
• Achieve quality by reducing the numbers of Customer Complaints and Deviation cases. Setting a target goal of not more than 4 Deviation cases and not more than 3 customer’s complaints.
• Achieve best shift of Yr 2009 and in Yr 2010 through team monitoring points awarding system.
• Achieved best record production output for 400g, 650/700g Pouches.
• Hiring, training and coaching of new and old employees with planning and organizing a transition group for the new S40 project (new production line).
• Assist the department for requirements in ISO and GCA audits.
• Conduct cross department internal audit on HACCP.

• Managing and Planning of the whole production material and manpower required to achieve monthly plan or customer’s purchase orders.
• Strategic planning of product type distribution in various processes to minimize lead-time and WIP control.
• Planning and conducting training for new and existing staffs (eg. Lead and Lead-Free Control, Countermeasure Procedures, safety, etc.)
• Daily monitoring of production output, quality and machines status.
• Improvement of new or existing manufacturing process flow and procedures.
• Supervise staffs in production and monitor production output.
• Support in operation of machines, machines buy-off and trouble-shooting of machine problems.
• Define abnormalities occurred in production and analyse statistical data gathered.
• Improvement activities on processes and machines based on analysis.
• Managing and control of product containment for quality issue and analysis.
• Manage monthly stocktaking activities, which include preparing, arranging and taking physical stock; facilitating finance stock auditing; compiling and summarizing monthly stocktaking results.
• Generate daily production report.
• Prepare monthly report (Machine downtime, Man and Machine efficiency and quality)
• Prepare monthly Material & cost saving report.
• Uploading and counter check quality ISO9000 check sheets.