Senior Scientist, Biologics Analytical Research & Development

* Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools.* Validate and implement analytical methods to support release and stability testing of clinical materials.* Support critical reagent qualifications and SoftMax Pro template validation activities.* Act as subject matter expert (SME) across various franchises and analytical platforms.* Support biologics registrations, product launches, and troubleshooting activities.* Develop and manage project timelines and deliverables.* Support compliance audits, inspection activities, and investigations/CAPAs.* Advance strategic initiatives across matrixed teams.* Document activities in a detailed and organized manner following ALCOA principles and SOPs.* Author and review technical documentation including regulatory submissions.* Additional responsibilities as assigned to support the evolving needs of the department.* Bachelor’s degree in biology, biochemistry or related science with 7 years of relevant experience in analytical development, validation, and/or quality control (QC)* Master's degree in biology, biochemistry or related science with 3 years of relevant experience in analytical development, validation, and/or quality control (QC)* PhD in biology, biochemistry or related science* Experience in the area of large molecules (vaccines, biologics) immunochemical and cell-based analytical methods.* Deep technical expertise with ELISA and cell-based potency methods.* Proficiencies with mammalian cell culture.* Experience with residual ELISA methods.* Strong organizational skills with proven ability to manage timelines and deliverables.* Ability to proactively identify and communicate risks.* Demonstrated capability of finding innovative solutions to technical issues.* Capability to work independently and within a matrixed team.* Effective communication (oral and written) and leadership skills.* Strong interpersonal skills with adeptness to lead by influencing others.* Self-motivated with a positive attitude and proven performance record.* Willingness to occasionally work irregular hours, including evenings and weekends, as needed.* Experience with deviation management and change control processes. **Preferred Experience and Skills:*** At least 1 year experience working in a GMP environment.* Experience with LIMS, SoftMax Pro, electronic notebook, and/or other data analytics platforms.* Knowledge of cGxP operation, USP, EP, ICH, and FDA guidelines.* Experience with analytical method validation and life cycle management.* Experience with method development or regulatory submissions.* Experience with SoftMax Pro template creation is highly preferred.* Experience with qPCR or compendial methods is desirable.**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
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