Scientist Ii Bioassay Automation Scientist

Hourly Rate: $46 - $50/hr with medical benefits available at a cost Contract Length: 1 year initial contract with possibility of extension Location: 100% onsite out of Irvine, CA Work Schedule: Monday – Friday standard first shift lab hours Orion Project Services and a market leading pharmaceutical company are teaming up for an exciting contract opportunity in Irvine, CA.
Our client is seeking a Bioassay Automation Scientist to support biologics programs through the development and routine execution of automated cell-based potency assays (CBPA) and quantitative ELISA (qELISA). This hands-on role combines bioassay and immunoassay work with opportunities to build technical and collaborative skills in analytical R&D while supporting development-stage and commercial programs.
Job Overview:
The Scientist works with the team to optimize bioassay workflows on automation platforms such as Opentrons and Hamilton liquid handlers and to keep those systems operational. Collaborating with scientific staff across biologics process development, formulation development, and stability studies, the individual plans and executes experimental work, analyzes data, and communicates findings. The role also includes preparing technical reports and contributions to regulatory filings, writing method and operational SOPs, and supporting method development under the guidance of senior scientists. The individual maintains a productive, collaborative laboratory environment consistent with regulatory and company expectations.
The position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

• Develop, qualify, and support routine operation of CBPA and quantitative ELISA testing utilizing Opentrons and Hamilton liquid handlers.
• Assist in transfer and validation of phase-appropriate bioassays and immunoassays for neurotoxin development programs.
• Create written procedures and protocols for analytical methods used to analyze and characterize biopharmaceuticals.
• Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals; maintain reagent supplies and laboratory notebooks; and summarize and communicate results to support timely delivery of quality methods.
• Comply with Quality Principals related to data generation and reporting.
• Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
• Author or revise protocols and SOPs, support training activities, and maintain laboratory operations consistent with departmental and company requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).
• Maintain a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of necessary equipment.
• Present technical data and project updates at team, departmental, and cross-functional meetings. Contribute technical data and subject matter expertise to regulatory submissions and interactions, as needed.

Preferred Qualifications

• Bachelor’s Degree in Biology, Biochemistry, Cell Biology, Biotechnology, or related scientific discipline with 2+ years of relevant experience, or Master’s Degree with 0 – 4 years of relevant experience.
• Experience with coding in Python or C++ (required)
• Experience with optimizing routines for systems such as Opentrons or Hamilton liquid handler systems.
• Hands-on experience with mammalian cell culture and in vitro cell-based assays.
• Experience with development, qualification, execution, or transfer of cell-based assays, functional assays, enzyme activity assays, or immunoassays.
• Experience with quantitative ELISA (qELISA) and other protein characterization assays.
• Knowledge of cell biology, molecular biology, immunoassays, and bioanalytical techniques.
• Experience maintaining laboratory notebooks, analyzing data, authoring technical reports, and following SOPs.
• Strong communication, organization, and teamwork skills.
• Working knowledge of GMP/GLP principles and documentation practices in a regulated environment is a plus.
• Experience with neuronal or neuroblastoma cell culture, potency bioassays, or functional characterization of neurotoxins is a plus.
• Experience with curve fitting in JMP or Prism is a plus.

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