Investigator, Analytical Sciences and Development
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.
• 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.
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.
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.
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.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
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.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Back to top