Investigator, Analytical Sciences and Development
The candidate will be primarily responsible for developing chromatographic separation methods and perform analysis for the characterization of small molecule NCEs, linkers and small molecule active drug with linkers for manufacture of Antibody-Drug Conjugates including identification and quantification of product & process related impurities The candidate could also be expected to develop other analytical methods and participate in testing for supporting of small molecule synthesis and Antibody-Drug Conjugates and Small Molecule-Drug Conjugates process development and manufacturing.
• Design and execute analytical method development and validation appropriate to phase and in line with QbD approaches.
• Lead and perform analytical work in accordance with stability protocols and batch analysis requirements as appropriate.
• Contribute significantly to innovative approaches to achieve project goals
• Collaborate with other teams/divisions within R&D and GMS to achieve project goals
• Make effective decisions to achieve desired outcomes of immediate work group.
• May be responsible for significant aspects of analytical transfer within/ between R&D and GMS
• Work to GMP standards when appropriate.
• Implement appropriate strategies, process efficiencies, and best practice
• Present effectively to internal GSK forums and external meetings.
• Share relevant scientific information from internal and external meetings with appropriate colleagues.
Perform appropriate Quality Control activities, including:
• Performing analytical testing to support release or rejection of intermediate, bulk and finished products by Quality Assurance
• Developing and proposing stability protocols.
• Developing and proposing specifications, sampling instructions, test methods and other Quality Control procedures.
• Monitoring any contract analytical testing
• Checking the maintenance of premises and equipment.
• Proposing validation protocols and performing appropriate validation of analytical methods.
Additionally, where delegation by a team leader or department director is applicable:
• Approving analytical test results to support release or rejection of intermediate, bulk and finished products by Quality Assurance.
• Approving specifications, sampling instructions, test methods and other Quality Control procedures.
• Approving any contract analytical testing
• Checking the maintenance of premises and equipment.
• Approving appropriate validation protocols and data for analytical method
MS with 7 years of pharmaceutical experience in analytical methods development, transfer, and testing, with a focus on drug substance or Ph.D. with 5 years of experience
Hands-on experience with systematic development and optimization of chromatographic separations, with emphasize on separation methods for small molecule NCE, Antibody-Drug Conjugates and Small Molecule-Drug Conjugates
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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