Job Details

  • Title: Sr Associate Scientist
  • Code: RCI-8236
  • Location: Thousand Oaks California (CA) 91320
  • Posted Date: 02/22/2021
  • Duration: 23 Months
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  Job Description

 

  • Independently design and execute experiments to characterize and enable implementation of new technologies that advance state-of-the art automation, high throughput screening, filling, and analytical capabilities.
  • Independently design and execute studies to characterize drug product formulations and processes to deliver robust products
    • Conduct studies to measure drug product stability under various stresses, e.g. formulation screening under accelerated or forced degradation conditions, UF/DF, filtration, and freeze/thaw, for products in various formulations and formats (liquid, lyophilized, vials, pre-filled syringes, etc.)
  • Evaluate product attributes through analytical testing, e.g. measurement of pH, conductivity, osmolality, protein concentration, SEC, CEX, subvisible and visible particle characterization.
  • Apply fundamental scientific and engineering principles (chemistry, kinetics, statistics, etc.) to solve challenges and evaluate effects of process stresses, process improvements, equipment, scale, and raw materials
  • Conduct analysis of data generated from the above listed activities, including statistical analysis using SAS, JMP, etc., and effectively communicate results
  • Serve as primary point of contact and subject matter expert (SME) on complex capabilities and own business process:
    • Write and own SOPs/methods/user guidance documents
    • Manage interface with project teams for successful execution of studies
    • Maintain equipment procedures, study log books, scheduling, metrics, training, etc.
  • Participate in data management initiatives, such as integration of data from lab instruments with Electronic Lab Notebooks (ELN) to streamline and automate data collection
  • Design, optimize and maintain Sharepoint site content
  • Troubleshoot malfunctioning equipment, work with Lab Operations, Asset Management and vendors to repair
  • Author/review technical documents, such as technical protocols, technical assessments, regulatory documents
  • Assist with and coordinate new equipment procurement and installation
  • Perform tasks related to safety and compliance initiatives in the lab, including resolution of observations
  • Manage inventory levels of commonly used lab supplies and chemicals

Preferred Qualifications:

  • Hands-on experience in designing and executing automation and high throughput screening studies on liquid handling platforms (e.g. Tecan, Hamilton, Andrew, Unchained Labs, etc.)
  • Hands-on experience in executing typical protein characterization techniques, i.e. SEC-UHPLC or CEX-UHPLC, concentration measurement via UV-Vis, viscosity, density.
  • Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire)
  • Familiarity and relevant knowledge of pharmaceutical/biotechnology process development, esp. formulation development and Drug Product unit operations, e.g. UF/DF, filling, lyophilization
  • Experience with Sharepoint and website design
  • Critical thinking, problem solving and independent research skills
  • Good organizational skills with strong attention to detail
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions/SOPs, and comply with company policies
  • Ability to elevate relevant issues to project lead and line-management
  • Excellent communication (oral and written)
  • Strong project management skills including the ability to manage project resource requirements (material, manpower, time, etc.)
  • 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, dynamic and highly matrixed team environment

Basic Qualifications:

B.S. with 2-5 years experience, M.S. with 0-3 years experience, with degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or related degree with a biotechnology, pharmaceutical or vaccine background. Biotech/pharmaceutical industry experience preferred.