Senior Scientist II, Biologics

Location: In-office, Aliso Viejo, California

Joining: Urgent

Salary: $57/hr or open to negotiation

What You’ll Do:

This position is within the Analytical Technologies team of the Applied Research department. This role focuses on developing, validating, and transferring analytical and biological potency assay and cell-based assay methods to support large molecule drug development and formulations from early-stage clinical studies through commercialization. The position also involves overseeing stability studies and conducting trending analysis. The position will establish, coordinate, and monitor analytical-related activities both internally and with CROs and CMOs to ensure quality and timeliness of projects. The ideal candidate works effectively and collaboratively with cross-functional groups and will represent as analytical lead on CMC project teams. This position is expected to communicate data both verbally at group meetings and through written documents and reports and be able to comfortably multitask across projects and disciplines.

• 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 the 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.
• Supports the 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.

Requirements:

• How You’ll Get There: 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. 
• The ability to independently lead investigations and troubleshoot technical problems at all stages of development, and to be 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 in 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, immunoanalytical/analytical chemistry, or related scientific field and 6 years of pharmaceutical industry experience in large molecule analytical development, drug product analysis, and regulatory submissions.