Associate 3, Drug Product Characterization

SAB • Sioux Falls, SD

9d • Onsite

About The Position

The Associate 3, Drug Product Characterization (DPC), will be responsible for developing and performing assays to characterize human polyclonal antibody (hpAb) immunotherapies. Assays will focus on describing aspects of drug product such as safety and potency, monitoring product consistency as well as mechanistic studies. Methods will include but are not limited to cell- and non-cell-based assays utilizing a variety of readouts, experience with cytometry is preferred. Experimental results will be summarized in an electronic notebook and communicated in weekly department meetings. Experimental procedures generated to characterize drug product will culminate in the generation of official Standard Operating Procedures (SOPs), Data Records (RECs), and formal reports, scientific writing experience preferred. While this position is predominantly focused on in-process testing, Good Laboratory Practices (GLP) are required and familiarity with lab work in a regulated setting is beneficial.

Requirements

• Bachelor’s degree in a scientific field.
• 3+ years of laboratory experience utilizing analytical procedures and equipment for flow cytometry, protein, nucleic acid, or cell-based assays.
• Familiarity with standard cell culture and aseptic techniques.
• Experience in developing and optimizing technical procedures.
• Experience with regulatory guidelines for GLP and documentation.
• Data analysis experience including GraphPad Prism and cytometry analysis.
• Strong analytical and problem-solving skills.
• Demonstrated proficiency using Microsoft Office applications (Word, Excel, PowerPoint and Outlook).
• Strong interpersonal communication skills, including writing technical reports detailing procedures, outcomes, and observations.
• High level of personal organizational and time management skills. Ability to complete assigned work accurately and within assigned timelines.
• Ability to work in a dynamic setting and adapt to new business needs.
• Ability to work effectively as a team member within the department and cross-functionally.

Nice To Haves

• Experience in immunology, cell biology or molecular biology is desired.
• scientific writing experience preferred.
• experience with cytometry is preferred.
• familiarity with lab work in a regulated setting is beneficial.

Responsibilities

• Support antigen and antibody development and characterization through routine testing and new assay development.
• Conduct varied laboratory procedures, which may include ELISA, multicolor cytometry, SDS-PAGE and western immunoblot analysis, live cell imaging, and molecular genetic techniques.
• Develop and optimize technical procedures, contributing to the creation of SOPs and RECs.
• Practice aseptic technique and tissue culture for in vitro experiments.
• Independently collect, evaluate, interpret, and document research data in an Electronic Laboratory Notebook (ELN).
• Support general laboratory operations, including reagent orders, supply maintenance, and preparation of buffers and media.
• Take a lead role in maintaining laboratory documentation and ensuring compliance.
• Collaborate with team members and across departments in the optimization of technical procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level