Expert Scientist, Drug Product Development

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

Preferred qualifications:

  • Management experience is a plus

Details:

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

  • LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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