Iris C.

At Syn-The-All Pharmaceutical (STA), an affiliate of WuXi AppTec, we provide “end-to-end” API development and manufacturing services including chemical synthesis route selection, process development and optimization, scale-up process research, GMP manufacturing of intermediates and APIs from kg to metric ton scale for phase I to commercial. Our services continue seamlessly with development services including pre-formulation & formulation development and clinical trial material supplies for production of Phase I - commercial materials including solid oral (including liquid filled hard gelatin capsules), sachets, liquid oral and topical semi-solid dosage. We offer a variety of services in both China and San Diego. Including, but not limited to; synthetic route development, process development and optimization, scale up, registration at our state-of-the-art Pharmaceutical manufacturing facilities that are capable of producing APIs and advanced intermediates from grams to hundreds of metric tons. You can now have a virtual visit to our facility through a click of the media link. If we can offer our service to your company, please feel free to reach out for a further discussion.

Provide consultancy service and support on Project Management

Patheon is a global leading service provider of drug substance and drug product services for the global biopharmaceutical industry. Key capabilities for biologics include flexible, technology-based process development, clinical and commercial cGMP manufacturing for mammalian cell culture derived biopharmaceuticals and chemical bulk drug substances. This role act as a liaison between the client and internal Product Development Service organisation to ensure all the needs are met. Key responsibilities: - Manage active projects, ensuring all assigned projects are delivered on time, managing the revenue and budget - Responsible for chairing all project meetings, teleconferences, face-to-face interactions, including the generation of team minutes - Generation, updating and facilitating agreement to project plans, including accurate revenue and resource forecasting, data transfer to Sales Order Register, and timely invoicing to client on completion of project milestones - Manage the generation, monitorin and control of assigned project worksheet, ensuring full transparency of performances versus budget for all assigned projects, within the project teas and with Senior Management team - Resolves project issues and resource constraints within the team - Communicate effectively internally and externally with a professional approach within the project teams - Provide positive leadership to the project teams both internally and externally - Manage client satisfaction by managing client expectations efficiently and maintain a good working relationship with client - Responsible for timely preparation, negotiation and approval of all Changes of Scope - Comply with GMP requirements

Key Achievements and Duties: - Manage the Vitamins and Minerals Supplements portfolio of projects, leading teams to design, plan and implement complex NPI and product change projects for global launch of products on multi-million pounds projects - Influence multiple stakeholders to prioritise, resource and govern projects from inception through to launch via stage gate process - Develop and deliver continuous improvement initiatives (resource analysis, budget and evaluate timeline) - Participated in stage gate process and documentation, ensuring relevance and compliance at all stages of product development from a technical perspective, highlighting risks involved throughout the gate process from both technical and business perspectives

Manage a small team of laboratory based analysts covering both microbiology and chemical analysis. My role involved significant coordination across other departments including NPD, QC, Regulatory Affairs, Quality Assurance, Production, Purchasing, and Marketing. My main responsibilities include: - Planning the workload for analysts under my supervision. - Undertake staff training and development to increase effectiveness, involved in appraising existing and hiring new staff. - Develop, write and implement stability protocols, SOPs, compliance documents, COSHH and H&S documentation, ensuring compliance with GMP, GLP and ICH requirements - Carry out analytical work testing the stability of new and existing products - Conduct out of specification investigations and implement necessary corrective actions. - Project management of new project initiatives and liaising with different company departments. - Management of stability testing in accordance with GLP/GMP - Supervise and lead a small team - Experienced in Pharmaceutical (or similar) testing for product stability - Excellent communication skills, organisation and time management skills

Q Chip is a specialist drug delivery company with expertise in the application of microfluidic droplet systems to formulate mono-dispersed biodegradable microspheres for the controlled release of active pharmaceutical ingredients (APIs). My role ranges from formulation and aseptic process development, assistant project manager (using Microsoft Project to generate Gantt Charts for project timelines) and work closely with executive team members. I also represented Q Chip and presented at both national and international business conferences to promote and establish collaboration with external business partners. Key Achievements: - Mentored and managed junior colleagues to enable efficient turnaround time for various projects - Successfully implemented technical transfer from Cardiff HQ to aseptic manufacturer in Netherlands - Communicated effectively with cross-functional departments and assisted the executive team to execute projects within the deadline

A nationally awarded research project on “Investigating the plasticity of stromal cells for cartilage repair”

Successfully awarded a position at British Heart Foundation and researched on “The oligomerisation of the cardiac ryanodine receptor amino-terminal domain”