Expert Scientist, Formulation & Process Development

GSK   •  

Rockville, MD

Industry: Biotech/Pharma


15+ years

Posted 370 days ago

Basic qualifications:
-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.

Key Responsibilities

-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


Requisition ID: WD117828