Senior Microbiologist

We’re hiring for a “Sr. Scientist – Analytical Development (Large Molecules/Biologics)” 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: Sr. Scientist – Analytical Development (Large Molecules/Biologics) 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. What You’ll Do: Provides technical expertise to design, conduct, and implement analytical and development activities for large and small molecules to support all stages of drug development. Troubleshoots and solves technical challenges independently in a timely manner and ensures generation of high-quality scientific data. Evaluates and interprets data from release and stability studies and provides scientific conclusions to support decision making. Maintains expertise in cutting-edge assay technologies and continuously develops excellent assay troubleshooting skills in analytical methodologies used for the characterization of drug delivery systems and protein formulations for drug release, potency, biological activity, stability, impurity testing and aggregation profile. Collaborate with protein/peptide engineering SMEs and contribute biological knowledge to the design of novel proteins with desired pharmacological characteristics. Prepares high quality experimental protocols and technical reports in support of regulatory submissions. Independently authors appropriate portions of CMC section of INDs, NDAs and prepares responses to regulatory questions. Provides training and guidance to scientists in the team. Provides regular and open communication to keep project teams, and management informed of direction, progress and strategic developments in supporting and meeting companies’ goals and objectives. Actively participates in departmental committees/meetings as an advisor in scientific, administrative and regulatory areas. Represents as analytical lead on CMC project teams, provides scientific solutions and contributes to team discussions. Support QC department with establishing robust methods, product specifications, method validations and method transfers. Proactively develops and maintains knowledge in current analytical and bioanalytical sciences and investigates new technologies, recommends and implements innovative techniques to the team. 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