Associate Scientist/Scientist, Drug Product Formulations & Analytics
Location:
Rockville , Maryland
Posted:
December 14, 2017
Reference:
WD136367
Basic qualifications:
PhD with 0+ years of experience OR
MS with 1+ years of experience OR
BS with 3+ years of experience
Degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field

Preferred qualifications:
• Prior experience with initiation of stability studies is preferred
• An understanding of QbD, ICH Guidelines, cGMP and FDA requirements for drug products would be helpful

Details:
We are looking for a motivated research scientist/associate scientist dedicated to driving innovative formulation solutions for novel vaccines in early stage research. Experience with formulation of recombinant proteins, nucleic acids, liposomes, nanoparticles, or vaccine adjuvants is required. Prior experience with initiation of stability studies is preferred. An understanding of QbD, ICH Guidelines, cGMP and FDA requirements for drug products would be helpful. This person will be also be responsible for supporting in vivo proof of concept studies, transfer of formulations in to late-stage development, and providing technical SOPs and reports supporting pre-formulation studies. This position requires excellent organizational skills and the ability to work in a highly collaborative environment.

KEY RESPONSIBILITIES

• Executes and assists with specific research and development projects in collaboration with the related platform staff, following the quality by design framework
• Responsible for the conception, design, implementation, and interpretation of scientific and technical data to support own area projects
• Collaborates with related platform staff and scientists to design, implement, and interpret the data from project work streams
• Makes sound scientific/technical decisions based on a balance of data, analysis and experience
• Functions effectively as a core team member on several projects and leads small projects 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 areas of preclinical research and 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 / Technical Development team or in Technical taskforce
• Be able to defend scientific data to external events, like congress
• Authors and reviews technical protocols and reports in support of various project development stages
• Utilizes technical process knowledge to meet "Fit for Purpose" and regulatory requirements appropriate for stage of development
• Communicates effectively within TRD and with external stakeholders
• Encourage adaptation and proactive promote the GxP / EHS / QA rules application

Contact information:

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