Associate Scientist

Job Title: Associate

Location: Thousand Oaks, California (On-Site)

B.S. and 1-2 YOE

Fully Onsite - Standard Hours

Description:

• As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products.
• The candidate will perform experiments, organize data and analyze results with minimal supervision.
• The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.

Must Have Skill Sets:

• Aseptic fill finish manufacturing or manufacturing technical services experience including the development of control strategies and active process performance monitoring
• Ability to use scientific principles to leverage bench and pilot scale models for process performance characterization
• Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.)
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
• Nice to have: Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes.
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
• Day to Day Responsibilities:
• Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management
• Apply basic science/engineering skills and first principles modeling to solve technical problems
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
• Report authoring and presentation of scientific data to team leads

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