Investigator, Analytical Sciences and Development

Your Responsibilities:
The candidate will be primarily responsible for developing chromatographic separation methods and provide preparative chromatography purification support to process development and scale up for small molecule NCEs, Small Molecule-Drug Conjugates. The candidate could also be expected to develop other analytical methods and participate in testing, technology transfer and help troubleshooting at manufacturing or a contract facility as needed.

Principal Accountabilities:
• Develop scalable separation processes for API scale up process for both early and late phase assets (including life cycle management).
• Evaluate the feasibility of the analytical-scale separation for scale-up separation processes, highlight any significant processing issues, and follow through on investigations of alternative approaches.
• Purify compounds for development studies according to project needs
• Plan, coordinate and transfer various aspects of scale-up preparative chromatography activities to ensure their success
• Perform appropriate analytical development/testing to support API/DP process development, release, stability studies and technology transfer, and may take on additional responsibilities such as contributing to regulatory dossiers and author/review expert reports, as required.
• Apply appropriate strategic/innovative technologies to improve processes and/or apply innovative solutions to project problems.
• Possess experience conducting separation with automated equipment
• Plan, design and execute work/experimental programs to further the course of product development and enable key decisions.
• May be responsible for supervising/monitoring work at a contractor or other remote facility
• Comply with the requirements of Quality (GMP standards), Safety and GSK policies and procedures and ensure that GSK intellectual property is protected.
• Must establish a strong working relationship and level of communication with colleagues within matrix team and as required with contacts from organizations external to GSK e.g. where there is a need to monitor projects or control the quality of data that are provided.
• Self-motivated with good organizational skills and ability to communicate in a scientific manner.
• Will prepare/present updates for cross departmental reviews and for governance fora as required and share relevant scientific information from internal and external meetings to appropriate colleagues.

Why You?

Basic qualifications:
MS with 7 years of pharmaceutical experience in analytical methods development and transfer, with a focus on scalable separation processes for drug substance or PhD with at least 5 years of related experience.

Preferred qualifications:
Extensive hands-on experience with systematic development and optimization of chromatographic separations, with emphasize on preparative chromatography and process purification.
Experience leading cross-functional projects across matrix lines.

Why GSK?:
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.

Contact information:
You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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