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Scientist II

Scientist II

On site

Irvine, United states

$ 48 /hour

Junior

Freelance

18-09-2025

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Job Specifications

Scientist II

$45 - $48/hr medical benefits available at a cost

1 year initial contract with possibility of extension

100% onsite in Irvine, CA

Standard first shift laboratory hours M-F

Orion Group and our largest US client are in immediate need of Scientists in Irvine, CA! Our client is seeking Scientists with prior experience with Cell-based potency assay / bioassay and quantitative ELISA (qELISA).

If this sounds like you then don't pass on this amazing contract opportunity to join a market leading pharmaceutical company!!!

Job Description / Responsibilities:

The Scientist is responsible for supporting the development, qualification, transfer, and validation of analytical methods.

Collaborates with scientific staffs to plan experimental work and executes protocols in support of biologics process development, formulation development, and stability studies. The individual independently generates, compiles, and evaluates data for technical reports to support regulatory filings for new and currently marketed biological products. The individual is also responsible for writing sections or subsections of technical reports, method and/or operational SOPs.

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 internal and applicable regulatory requirements.

Support development of phase appropriate separation methods to support toxin development programs
Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Create written procedures and protocols. Transfer, qualify or validate methods as needed.
Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Maintain reagent supplies, notebooks, summarizes results in written reports and communicates observations to ensure that the end user receives quality methods in a timely manner. 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.
Develop protocols and SOPs, train staff and maintain the laboratory 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 and defends product, assay and process data to regulatory agencies.

Qualifications Needed:

Bachelor's Degree or equivalent education with at least 2 years of experience, or Master's Degree or equivalent education with typically 0 - 4 years of experience.
Experience in the area of developing and qualifying in vitro cell-based assays to reflect the relevant molecular mode of action.
Experience in cell culture and state-of-the-art cell and molecular biology, immunoassay, and bioassay techniques.
Knowledge and experience in developing, validating, and transferring separation methods for biologics, including qELISA (quantitative), Cell-Based Potency Assays (CBPA), enzyme activity / functional assays and other bioassays.
Understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
General understanding in CMC development strategy of biologics drugs is expected.
Understanding of how neurotoxin structure relates to biological function is a plus.

About the Company

Established in Scotland in 1987, Orion Group achieved consistent growth over the ensuing 38 years and is now an international leader in the provision of personnel. We manage thousands of contractors and permanent placements from our worldwide network of offices throughout the Americas, the UK and Europe, the Middle East and Asia Pacific regions. Know more