Mildred Rodriguez Email & Phone Number

Cary, NC, US

Stamford, Connecticut, US

Stamford, Connecticut, US

• Provide leadership and work with CROs/CMOs to design and perform method development and validation employing phase-appropriate approaches at different stages of development for assay, purity and dissolution.
• Coordinate, monitor and evaluate project progression at contract manufacturers and ensure the timeliness and quality of deliverables.
• Review and provide oversight of all documentation related to the analytical testing of drug substance and drug product, including but not limited to development reports, validation protocols/reports, stability.
• Author/review analytical sections of CMC modules in regulatory documents including IND, IMPD, NDA, MAA and other regulatory submissions.
• Oversight of GMP QC activities (release and stability testing, investigations) for clinical, registration, and scale-up lots
• Supported manufacturing campaigns, impurity fate and purge and DOE studies

Cambridge, MA, US

- Provided technical expertise on analytical methodologies for small molecules and ASO drug substance and drug products-Performed Phase III readiness assessment for different products going from Phase I/Phase II into Phase III and from Phase III to Commercial including evaluating the state of analytical methods and specifications and their compliance with.

Salisbury South, SA, AU

Manage analytical technical transfers at European CMO for commercial productsStrengthen business relationship with CMO/CRO Successful completion of transfer activities in compliance with ICH, FDA and EMA regulationsCollaborate with QA during CMO QA auditsReview and approval of laboratory investigations, protocols, specifications, test methods and.

Foster City, CA, US

Supported NDA filing by authoring method validation sections, reviewing data and participating in internal auditsContributed to justification of specification for dissolution method involving a combination productManage review of CRO method validation data and reportsProvided training and manage a team of consultants working on electronic data integrity.

Foster City, CA, US

Lead Laboratory Investigations and Deviations team for Analytical OperationsWork with Quality consultants to enhance our Deviations and CAPAs quality systemManage GMP & Method Training Team Evaluate and revise Analytical Operations SOPs Supervise chemists conducting method validationAuthor method validation protocols and reports Support internal.

Foster City, CA, US

Applied LCMS technique to ensure suitability of LC assay/impurities methods. As a result, a degradation product discovered in Tybost® during Phase III was successfully characterized and a suitable method was developed to quantitate this impurity.Supported regulatory filings by writing and reviewing analytical development sections with emphasis on stability.

Ph.D, Chemistry

B.S, Chemistry