Jobs · Research · California

Research Associate

WhiteCap Search · San Diego, CA · 2 days ago
On-siteResearchContract
This position involves working collaboratively with research, quality control (QC), and process development teams to develop analytical methods for AAV gene therapy. The role requires contributing to the development of robust separations-based methods for drug substance and drug products. This is a 7-month contract position based in San Diego, CA.Collaborate with teams to develop analytical methods under the guidance of a scientific mentor.Contribute to the development of separations-based methods (e.g., HPLC, UHPLC, CE-SDS) for drug products.Participate in developing timelines, protocols, studies, and reports for method development and assay transfer.Author and review analytical/equipment logbooks, protocols, and reports as needed.Assist in the timely execution of testing for routine in-process analytics, data review, and preparation of summary reports.Perform additional analytical development activities such as routine instrument maintenance or quality-related exercises as needed.Maintain laboratory, support other divisions as needed, and ensure equipment is operational.Software Use ExpectationsUtilize Chromeleon CDS to acquire and process data.Utilize statistical analysis software (e.g., JMP) to evaluate data, identify trends, and recommend assay acceptance criteria.QualificationsKnowledge and hands-on experience in analytical and separations-based assays, particularly in the context of AAV gene therapy products.Experience in supporting studies and method development from Analytical Development into Quality Control (QC).Assist in routine analytics to support product- and process-related characterization.Develop and perform analytical methods to support QC lot release and stability of gene therapy products.Bachelor's degree or equivalent in a relevant discipline with 2-5 years of relevant industry experience or a Master's degree with 0-2 years of relevant industry experience.Experience in the pharmaceutical industry preferred, covering analytical method development and knowledge of QC testing.Strong, hands-on experience in HPLC and other separation-based technologies, including standard maintenance and troubleshooting.Willingness to take on new challenges required to bring medicines to the clinic.Excellent organizational and communication skills.Experience with Chromeleon CDS and JMP statistical software is a plus. Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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