Separation Scientist, Analytical R&D (Onsite)

* Validate and implement analytical methods to support release and stability testing of clinical materials.* Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP).* Act as subject matter expert (SME) across various franchises and analytical platforms.* Support biologics registrations, product launches, and troubleshooting activities.* Support compliance audits, inspection activities, and investigation/CAPAs.* Author and review technical documents.* Complete assigned work within established project timelines.* Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes.* Manage laboratory equipment, laboratory supplies and critical reagent inventories.* Additional responsibilities as assigned to support the evolving needs of the department.* At least 1 year experience working in a GMP environment* Experience with separation techniques such as HPLC, UPLC, CE, iCIEF, or other advanced technology.* Additional responsibilities as assigned to support the evolving needs of the department.* Understanding and adherence to ALCOA principles for documentation.* Strong organizational skills and ability to manage work to meet project timelines.* Capability to work independently with minimal supervision.* Ability to identify and resolve common technical issues.* Effectively engage, communicate, and collaborate with others.* Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning.* A willingness to occasionally work irregular hours, including evenings and weekends, as needed.* Technical expertise with compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity.* Knowledge of USP, EP, ICH, and FDA regulations.* Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms.* Experience with electronic notebooks.* Experience with Mass Spectrometry analysis.* Knowledge of deviation management and change control processes.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr