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Contribute to the successful and timely validation, transfer and implementation of BioPharm Analytical methods/technologies to and from R&D development, contract manufacturer s, testing labs, or GSK commercial manufacturing organizations.
Own and manage method life cycles applying appropriate statistical tools to assess assay capability, and participate in method qualification/validation strategies consistent with ICH requirements and current regulatory opinion.
Expanding technical knowledge beyond own area of expertise into e.g. cell culture, fermentation, protein purification, cell banking, engineering, quality, regulatory, operational excellence, secondary manufacturing and using this knowledge to streamline/ enhance Analytical Technology Transfer.
Oversee and coordinate method qualification/validation activities insuring minimum ICH/FDA requirements are met where appropriate and consistent approaches are applied across analytical methods.
Ensure alignment of testing strategies with GSK quality standards as assets progress through development stages.
Work with QA, Document Control and Validation groups to ensure quality standards are maintained and/or enhanced. Attend team meetings and participate in continuous improvement initiatives.
Collaborate with GSK Analytical Development Groups and serve as a liaison on technical issues with secondary customers. Ensure ongoing performance of analytical methods.
Contribute to product specification development for assigned projects and ensure alignment with process/method capabilities.
Responsible for authoring and revising SOPs, methods, transfer/ validation protocols/ reports, and other laboratory documentation as necessary.
Actively involved with project/matrix teams as assigned
Business travel is expected to be up to approximately 15%
If you have the following characteristics, it would be a plus:
Key responsibilities include:
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
We want to help people do more, feel better, live longer
We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time. Find out more about how we are doing more across the US
As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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