Responsible for process development and setting the control strategy for assigned NPIs and leading the technical transfer of innovation products from pilot plant to factory-scale, working in conjunction with Supply Chain.
To provide life cycle oversight of GSK products from Scale Up of NPI’s through Stewardship of new and existing products on the market. This includes applying learning from Stewardship projects to future NPI’s.
Lead the manufacture and scale up of development batches and technology transfer of new products into commercial manufacturing facilities to the required cGMP standards.
Manage multiple projects and be able to focus and prioritize on important projects.
Deliver robust, efficient & validated manufacturing processes for NPI and Stewardship projects.
Contributes to the Development report and Technical Risk assessment and sets the Control Strategy for NPI's and relevant Stewardship projects.
Manage and lead process development activities on prioritized projects in China & wider APAC in collaboration with NPD & Supply Chain teams (Technical, Engineering, Quality, Procurement)
Lead process engineering studies to identify new and improved processing techniques and technologies for introduction into R&D and Supply Chain.
Author, review, authorize GMP-critical documentation, such as experimental reports, batch records, development and technology transfer reports.
Engage with R&D and Supply Chain functions to understand technologies employed in Category and Regional products and associated challenges
Lead the scale up/down from pilot plant to commercial scale, developing technical understanding and scale-up rules that can be used by other engineers (Quality by Design).
Develop processing equipment understanding/characterization – at different scales to be able to develop scale-up models.
Develop a strong understanding of how key product quality attributes can be influenced by processing and can therefore be controlled (Process Understanding Control and Capability)
Plan and implement process development experiments at laboratory and / or pilot plant (1/10th) scale, using agreed engineering tools such as DOE and report the results
Independently design experiments and carry out scientific work with a good knowledge of state-of-the art technology. Create investigation and research plans to fit overall project objectives.
Exercise a wide degree of independent, technical sophistication in accomplishing assigned objectives
7y (BS); 4y (MS); 2y (Ph.D.) experience in process development, with good understanding of CH / FMCG product development process
Good understanding of CGMP requirements
Successful track record of OTC / CH Process Development.
Experience in the field of product cost optimization, value engineering and Operational Excellence
Good communication and influencing skills in a complex, matrix environment
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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