Experience

H&H Group

• Hong Kong
• Retail Health and Personal Care Products
• 400 - 500 Employee

• Project Manager - PMO

  • Aug 2022 - Present

  Melbourne, Victoria, Australia



PCI Pharma Services

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Manager

  • Mar 2020 - Aug 2022

  Melbourne, Australia - Lead projects and acted as primary liaison for the sponsors (Product Development companies) to discuss project requirements and updates through-out project life-cycle, chaired meetings and reported regularly on project milestones to senior management at PCI and clients. - Assisted business development with service proposals and contract management. - Tracked and evaluated end-to-end product manufacture at various stages through active co-ordination with warehouse, quality, operations… Show more - Lead projects and acted as primary liaison for the sponsors (Product Development companies) to discuss project requirements and updates through-out project life-cycle, chaired meetings and reported regularly on project milestones to senior management at PCI and clients. - Assisted business development with service proposals and contract management. - Tracked and evaluated end-to-end product manufacture at various stages through active co-ordination with warehouse, quality, operations and logistics teams, to ensure on-time delivery for clinical trials.Identified project-specific bottle-necks and critical quality-related requirements, conducted risk assessment for effective management of project schedule, budget and invoicing. - Created GMP documentation - manufacturing batch records (MBRs), product release specifications, shelf-life assessments and justifications for investigational medicinal products. - Reviewed and approved product labels for clinical trial as per Annex 13 of PIC/S Guidelines. - Assisted QA with supplier qualification and vendor assurance assessments, equipment qualification. - Assisted clients with tech-transfer, process validation, stability program requirements. - Performed investigation and closure of deviations, implemented corrective and preventive actions. - Championed process improvements, applied LEAN/Six Sigma principles to enhance efficiency of processes. - Trained associate project managers and other teams on project management processes. - Resumed higher duties in absence of Head of Projects. Show less



MTPConnect

• Australia
• Biotechnology Research
• 1 - 100 Employee

• Project Manager

  • Oct 2017 - Feb 2020

  Melbourne, Australia • Planned and implemented delivery of funding programs including inaugural round of BioMedTech Horizons program, a $10 million funding program for biomedical research to progress discoveries through proof-of-concept. • Strategically managed projects using financial tracking and reporting tools; reviewed technical progress of funded biomedical research projects against milestones and made recommendations to senior management to approve/withhold payments. • Supported monitoring, evaluation… Show more • Planned and implemented delivery of funding programs including inaugural round of BioMedTech Horizons program, a $10 million funding program for biomedical research to progress discoveries through proof-of-concept. • Strategically managed projects using financial tracking and reporting tools; reviewed technical progress of funded biomedical research projects against milestones and made recommendations to senior management to approve/withhold payments. • Supported monitoring, evaluation and reporting obligations for the program; prepared half-yearly reports on progress and outcomes of research funding and administration. • Supported the CEO and GM International & Government with activities and initiatives in the international portfolio aligned with the MTPConnect’s business plan and to managed liaisons with the Commonwealth Dept of Health on a regular basis. Show less



Australian Pharmaceutical Manufacturers (APM)

• Quality Assurance Associate - Batch Releases

  • Feb 2016 - Sep 2017

  Melbourne, Australia • Reviewing manufacturing and release documents for strict compliance product/material specifications, regulatory and GMP requirements. • Assessing, evaluating and reviewing results of analytical manufacturing tests ensuring process control procedures are followed, Prepare Annual product quality review (PQR) • Identifying and reviewing deviations, assessing risks and suggesting Corrective and Preventive actions (CAPA) to address concerns in product quality • Application of root cause… Show more • Reviewing manufacturing and release documents for strict compliance product/material specifications, regulatory and GMP requirements. • Assessing, evaluating and reviewing results of analytical manufacturing tests ensuring process control procedures are followed, Prepare Annual product quality review (PQR) • Identifying and reviewing deviations, assessing risks and suggesting Corrective and Preventive actions (CAPA) to address concerns in product quality • Application of root cause analysis in customer complaints investigation • Reviews change activity to ensure compliance • Acts as control checkpoint for final and/or in-process release authorization and issuing Certificate of Analysis and Certificate of Conformance to Sponsor • Liaise with third party companies (testing laboratories, logistics) and Sponsors • Supporting the Regulatory and QA team at the Sponsor's end by liaising with them regarding process changes and batch documentation, ongoing stability studies • Assist in internal and third-party audits (TGA audits, Sponsor audits), GMP training. Show less



MTPConnect

• Australia
• Biotechnology Research
• 1 - 100 Employee

• Program Consultant - China Inbound Innovation Mission to Australia

  • Apr 2017 - May 2017

  Melbourne, Australia • Worked closely with the Chinese delegates and Australian MedTech researchers and companies to facilitate meetings, and highlight opportunities for organisations in both countries to collaborate and develop new products and services. • Coordinated regularly with Austrade to ensure smooth program development and logistics • Identified suitable Australian MedTech companies and partners that match delegate profile • identified and secured companies in Victoria and NSW that are best… Show more • Worked closely with the Chinese delegates and Australian MedTech researchers and companies to facilitate meetings, and highlight opportunities for organisations in both countries to collaborate and develop new products and services. • Coordinated regularly with Austrade to ensure smooth program development and logistics • Identified suitable Australian MedTech companies and partners that match delegate profile • identified and secured companies in Victoria and NSW that are best placed to present at the event Show less



Asahi Beverages

• Australia
• Food and Beverage Services
• 700 & Above Employee

• Quality Control Officer

  • Sep 2015 - Jan 2016

  Melbourne, Australia • Implementing HACCP by online monitoring of Critical Control Points on the filler lines • In-process product sampling and testing of critical product quality parameters • Extensive knowledge on Food Standards Code, Food safety and quality control.



Eurofins Environment Testing - AUS/NZ

• Australia
• Environmental Services
• 100 - 200 Employee

• Laboratory Assistant

  • Sep 2015 - Sep 2015

  Melbourne, Australia • Filtering and Preparation of soil samples for heavy metal detection using ICP-AES • Preparation of soil samples for detection of Chlorinated organic compounds using Gas Chromatography • Preparation of water samples for hexavalent Chromium ions using Wet chemical methods and analysing by UV-vis Spectrophotometer • Calibration of instruments and implementing GLP and trained in Workplace Health and Safety regulations.



Granules India Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Intern- Operational Excellence

  • Dec 2013 - May 2014

  > Troubleshooting Lumps formation during Wet Granulation in a Rapid Mixer Granulator > Root cause analysis of formation of lumps during granulation of Paracetamol & Metformin HCl > Devised a method to study the API powder wettability > In-depth analysis of role of solvent in Wet Granulation in RMG



Laurus Bio

• India
• Biotechnology Research
• 200 - 300 Employee

• Junior Production Executive

  • Dec 2011 - Jul 2012

  > R&D Training in Upstream and Downstream Fermentation of Picchia pastoris > Protein Estimations (Bradford Method, SDS-PAGE) , Separations (Micro and Ultra Filtration, Affinity Chromatography) > Microbiology Techniques > Training in Validation- DQ,IQ,OQ,PQ of various Biopharmaceutical Instruments > Preparation of SOPs and Documentation compliance



ExCel Matrix Biological Devices

• Intern - 3D Animal cell Culture

  • Jan 2011 - Jun 2011

  # Acquiring in-depth and vast knowledge of animal cell culture # Hands-on experience in 3-d cell culture # Method development and validation of Alcian Blue Assay forGAGs in Cartilage tissue grown on 3D scaffold # Planning an executable experiment # Microscopy and staining techniques PROJECT: Estimation of Glycosaminoglycans in cartilage: Devised and optimized a protocol to estimate the amount of Glycosaminoglycans in the cartilage tissue and culture using a cheaper and… Show more # Acquiring in-depth and vast knowledge of animal cell culture # Hands-on experience in 3-d cell culture # Method development and validation of Alcian Blue Assay forGAGs in Cartilage tissue grown on 3D scaffold # Planning an executable experiment # Microscopy and staining techniques PROJECT: Estimation of Glycosaminoglycans in cartilage: Devised and optimized a protocol to estimate the amount of Glycosaminoglycans in the cartilage tissue and culture using a cheaper and reliable method, ALCIAN BLUE ASSAY. Show less



HSBC

• United Kingdom
• Financial Services
• 700 & Above Employee

• Customer Service Executive

  • Nov 2006 - Apr 2007

  • Handled In-bound & Out-bound Calls to HSBC clients in United Kingdom regarding the Stocks & Shares Applications and processing. • Co-ordinate with Financial Planning Managers in U.K. to resolve queries regarding the applications • Responsible for approval/rejection of applications based on a set criteria • Meet the monthly KPIs set by the organization • Garnered excellent communication skills as I was trained for a month by the HSBC to work competently in the role.