Analytical Scientist - Microbiologist

We’re hiring for a “Analytical Scientist - Microbiologist” role in “Aliso Viejo, CA (Onsite)” with one of our industry-leading clients. This is a long-term opportunity, with competitive pay, and the team is actively scheduling interviews. Role: Analytical Scientist - Microbiologist Employment Type: Full-Time Must have: Analytical Methodical developments for large molecules Able to collaborate with the team. Be able to engage and work with CRO and CDMO. How You’ll Get There (Requirements): Strong hands-on knowledge of chromatographic theory and technology. Working knowledge of HPLC, UPLC, IEX-HPLC, SEC-HPLC, LC-MS, CE techniques, cIEF, MSD, ELISA, ddPCR, qPCR, Octet, Biacore, and other common analytical and bioassay techniques used to determine potency, purity, and in-vitro performance of drug substance and drug product for large molecules. Ability to independently lead investigations and troubleshoot technical problems at all stages of development, being detail oriented are important attributes. Excellent written and verbal communication skills; prior experience working within regulated environments (e.g., GxP, ICH, FDA) to ensure analytical activities meet compliance standards and support regulatory filings and inspections. Strong ability and knowledge to develop, validate and transfer methods. Experience in oversight of stability studies, conducting trend analysis and interpreting data. Strong scientific and leadership skills with the ability to be a subject matter expert at matrix teams and influence and collaborate. Ability to work within a diverse workforce, scientific participation and collaboration with colleagues in industry, academia and regulatory agencies. Experience in interacting with pharmaceutical CROs and CMOs and providing guidance. Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. Good knowledge of drug development and product regulations. Ph.D. (with 8+ years) or M.S. (10+ years) in biochemistry, immune analytical/analytical chemistry, or related scientific field and 6+ years of pharmaceutical industry experience in large molecule analytical development, drug product analysis and regulatory submissions. #J-18808-Ljbffr Trident Consulting