Robert Daly Email & Phone Number

San Francisco, Ca, Us

San Francisco, Ca, Us

Supports clients to manage CMC timelines from a technical/scientific perspective.Designs, supports and analyzes method transfer and validation activities in a phase appropriate manner.CDMO oversight:Provides technical input for selecting external contractors.Manages day to day analytical activities.Regulatory Submissions:Authors and reviews CMC sections of regulatory submissionsSupports responses to questions and requests for additional information.Identify, communicate, and escalate potential regulatory issues.Authorship of Development plans, SOPs, Qualification/Validation protocols and reports.Cell based and non cell based relative potency assay development, transfer and validation.Reference Standard (Primary and Working)/Critical Reagent managementOOS/OOT InvestigationsBiochemical characterizationForced degradation studiesDue diligenceCMC gap analysisFormulation developmentProtein production and purification

Analytical method development, optimization and transfer in support of a small molecule therapeutic.Improved PK ELISA to overcome matrix interference to support preclinical studies in monkeys and canines.Reformatted Drug Product potency assay to enable qualification in support of Phase 1 clinical trial.Recommended appropriate equipment for purchase.Hired and managed staff.

South San Francisco, Ca, Us

Method development, transfer and troubleshooting in support of the commercialization of a protein therapeutic. Drafted Primary Reference Standard qualification protocol. Participated in OOS investigations writing deviations and recommending CAPAs. Transferred two potency assays to CRO for validation. Drafted responses to FDA Requests for Information.

Developed and transferred a variety of analytical, bio-analytical and purification methods to multiple CROs to characterize antibody therapeutics in support of GMP manufacturing, stability studies, and clinical trials. Worked with CROs to improve and/or replace existing methods. Developed subcutaneous formulations for two antibody therapeutics.

Counseled clients in formulation and analytical method development.

Us

Improved the liquid formulation of an adjuvanted anthrax vaccine. Developed stability indicating biophysical characterization assays to elucidate the degradation pathway and identify stabilizing excipients. Managed in house stability studies and coordinated material delivery for multiple off site immunogenicity studies.

Us

Emeryville, California, Us

Education record

Education record