Job Details

  • Title: Associate Scientist
  • Code: RCI-6990
  • Location: Thousand Oaks California (CA) 91320
  • Posted Date: 02/14/2020
  • Duration: 36 Months
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  Job Description

Associate Scientist responsibilities include, but are not limited to, the following:

  • Independently design and execute studies to characterize Drug Product formulations and processes to deliver robust products
    • Conduct related studies, such as ultrafiltration/diafiltration (UF/DF), filtration, freeze/thaw, filling, and material compatibility, for products in various formulations and formats (liquid, lyophilized, pre-filled syringes)
    • Conduct analytical testing of samples, such as measurement of pH, conductivity, osmolality, protein concentration, SEC, CEX, particle concentration, visual appearance
  • Independently design and execute experiments in order to characterize and enable implementation of new capabilities that advance state-of-the art automation, high throughput screening, formulation, filling, and analytical technologies
  • Apply fundamental scientific (biochemistry, biophysics, statistics) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
  • Serve as single point of contact and subject matter expert (SME) on complex capabilities. Enable walk-up utilization and own business process:
    • Write and own SOPs/methods/manuals
    • Provide equipment and assay training
    • Manage interface with project teams for successful execution of studies
    • Maintain equipment procedures, user log books, scheduling, metrics, training
  • Conduct analysis of data generated from any of the above listed activities, including statistical analysis using SAS, JMP, and effectively communicate results
  • Troubleshoot malfunctioning equipment, work with Lab Ops, Asset Management, Facilities and vendors to repair
  • Author/review technical documents, such as technical protocols, technical assessments, technical reports, regulatory documents
  • Assist/coordinate new equipment procurement and installation
  • Perform tasks related to safety and compliance initiatives in the lab; inspections and resolution of observations
  • Manage inventory levels of commonly used lab supplies and chemicals
  • As needed, participate in initiatives, such as integration of Electronic Lab Notebooks (ELN) and lab instruments to streamline and enhance data collection
Preferred Qualifications:
  • Strong scientific skills relevant to Drug Product development
  • Display critical thinking, problem solving and independent research skills
  • Good computer and organizational skills with strong attention to detail
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Ability to elevate relevant issues to project lead and line-management
  • Excellent communication (oral and written)
  • Excellent project management skills including the ability to manage project resource requirements (material, manpower, time)
  • Self motivation, adaptability and a positive attitude
  • Ability to work independently and as part of a team with internal and external partners
  • Ability to participate in cross-functional teams and work effectively in a fast-paced, highly matrixed team environment
  • Team leadership and supervision skills
  • Experience working with GMP systems
  • Experience in process development for Phase I – III biologics