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Sr Research Scientist I, Analytical Development

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

We are seeking an Analytical Development Sr Research Scientist with Biologics experience to join our rapidly growing Oceanside team.

Specific Responsibilities:

  • Lead the development of robust chromatographic-based analytical assays for proteins, conjugates, or related biologics. This includes analytical SEC, IEX, HIC, and RP-HPLC methods.
  • Be knowledgeable in the latest advances in chromatography columns and systems for biologics analysis and have a successful track record of developing and transferring new separation methods into QC labs for release and stability testing.
  • Develop and implement a method lifecycle management program for separation methods to ensure optimal and consistent method performance across the development and QC testing labs.
  • Remediate technical issues and lead investigations involving HPLC-based analytical methods.
  • Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, independently champion technology development projects, be involved in new assay evaluation and optimization, write/review development summary reports and author regulatory submissions.
  • Define critical reagents and pCQAs, and propose phase appropriate specifications for both drug substance and drug product.
  • Serve as an analytical development representative on pharmaceutical development project teams.
  • Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
  • Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
  • Lead, motivate, and develop the people in their group.
  • Routinely make decisions affecting direction of project to ensure project timelines are met.
  • Review and approve technical reports. Lead presentations in technical review.
  • Maintain strong knowledge of GMPs.
  • Direct research associates or members of project teams (as needed) in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors. Work on a wide - range of problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.



Essential Functions:

  • Responsible for conducting scientific research for the development of drug candidates or the research support of marketed drugs.
  • Applies the principles and techniques of Analytical Chemistry to biologics development.
  • Works under supervision of more senior scientists or scientific directors to advance the development of state-of-the-art techniques to characterize biologics.
  • Advises Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
  • Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
  • Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company interests.
  • Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
  • May make contributions to scientific literature and conferences or regulatory filings.
  • Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.



Knowledge, Experience and Skills:

  • PhD in a relevant scientific discipline with ≥ 5 years of industry experience.
  • BS or MS degree with extensive industry experience.
  • Supervision experience is desired.



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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Sr Research Scientist I, Analytical Development

Oceanside, CA
Full Time

Published on 11/08/2018