Job Details

  • Title: Research Scientist
  • Code: RCI-AZ-10888
  • Location: Gaithersburg Maryland (MD) 20878
  • Posted Date: 08/14/2019
  • Duration: 6 Months
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  Job Description

The Scientist I/Scientist II is a temporary position in Drug Delivery group in Dosage Form Design and Development department of Biopharmaceutical Development organization. Will closely work with the CMC lead to advance products through early-to-late stage development to support phase 1 to 3 clinical trials.

  • Solid state material characterization to identify critical parameters that set the quality and governs optimum and consistent dug product performance
  • Identify critical steps in the manufacturing process that controls material polymorphs, reproducibility and scalability
  • Identify critical quality attributes of materials/drug products to set clinical phase appropriated specifications
  • Set materials on stability to evaluate quality and shelf life of the material
  • Identify solid forms with different properties to overcome development challenges
  • Review technical documents, progress reports, specifications/COAs from manufacturers or suppliers and keep abreast with development activities
  • Align with different CMC functions - regulatory, quality, analytical, formulation – to deliver material/product with phase appropriated quality
  • Timely communication of important and critical issues arising from suppliers to CMC lead and the team with clear details and potential solutions
  • Understand manufacturing process to identify critical process parameters to support process improvements, reproducibility and cost reduction
  • Attention to details and quick response to new developments during processes. Managing competing priorities in a fast phase development timeline
  • Manage and stay on top of material related quality investigations, working with functions to take steps to trouble shoot and close investigations timely manner
  • Manage materials to support various needs and suppliers in setting up/renewing contracts as required, issuing new purchase orders routing for approval through management chain
  • Develop material manufacture and use history for traceability. Manage material shipping and receiving by working closely with LCS (logistics and clinical supply) team
  • Help drafting of technical sections of regulatory submission documents related to materials and products, EOP2 briefing documents and questions/answers to various agencies
  • Assess current product quality and devise phase 3 enabling material development plan
  • Work with material sourcing group to identify and screen suppliers, develop materials to set quality/specification. Identify steps to reduce cost
  • Involve in setting process parameter range and validation of manufacture process technology transfer
Qualifications and preferred skills:
  • PhD/MS/BS degree in chemistry, material science, pharmaceutical or related physical or life science discipline and 3-10 years of relevant experience related to pharmaceutical development
  • Experience in pharmaceutical product development in solid oral dosage forms
  • Possess technical knowledge of biopharmaceutical properties of critical material
  • Understand critical quality attributes of each material in drug product performance
  • Ability to assess the risks of a situation, their potential impact on a project and timely communication with internal and external partners
  • Experience in scalability assessment and trouble shooting
  • Verbal and technical writing skills
  • A flexible attitude with respect to work assignments
  • Excellent analytical and problem-solving skills
  • Excellent organizational skills and managing of multiple suppliers
  • Knowledge and understanding of current Good Manufacturing Practices (cGMPs)
  • Proficient in MS suite of software tools (PowerPoint, Excel, Word)
  • Project Management skills
  • Drafting and authoring regulatory document experience is a plus