Expert Scientist, Formulation & Process Development
-PhD with 3+ years of industry experience OR
MS with 6+ years of experience OR
BS with 15+ years of experience
-A good understanding of vaccine formulation science, freeze-drying technologies and key analytical assays is required
-Knowledge about physical characterization of the vaccine formulation using high-end instrumentation is required
-Must have experience supporting drug product process transfers to clinical manufacturing for all phases of development
-Ability to effectively work and perform within a team of dedicated scientists is essential
-Must be able to solve complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment
-Requires conceptual and practical experience with the project management function
-Must have the ability to work with cross-functional teams and communicate effectively
-Management experience is a plus
The Expert Scientist is expected to lead, design and execute scientific studies in support of technical programs as they progress from early development into Phase I/ II, Phase III, technology transfer and process performance qualification at the intended commercial site.
-Designs and leads specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework
-Independently responsible for the conception, design, implementation, and interpretation of scientific and technical data to support projects
-Collaborates with and/or leads scientific staff to design, implement, and interpret the data from development workstreams.
-Makes sound scientific/technical and business decisions based on a balance of data, analysis and experience
-Functions effectively as a core team member on multiple concurrent project workstreams and established work processes
-Solves complex problems through collaborations with others, taking a new perspective on existing solutions
-Provides guidance to new team members and acts as a resource for colleagues with less experience
-Generates strong relationships in the area of technical development with high quality partners beneficial to the organization, both internally and externally, to strengthen development/implementation of new methods/technologies
-Prepares and presents scientific data within Technical R&D including Technical Development Team and may represent GSK externally (conferences, etc)
-Authors and reviews technical protocol, reports and manufacturing support documents in support of various project development stages
-Utilizes technical process knowledge to meet regulatory requirements appropriate for stage of development
-Communicates effectively within TRD and with external stakeholders and is able to defend scientific and technical decisions at the appropriate technical board
-Benchmarks specific technologies in own functional area to bring technology to state of the art
-Contributes to and drives strategy and technical development planning and accountability in the execution thereof
-Ensure execution of the function's risk assessment and escalate at relevant bodies. Development of mitigation plans
-Act as a voice and ambassador of its department at various governance bodies / meetings
Leads and implements the respect of the GxP / EHS / QA rules application
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.