Carmen Robles Email and Phone Number

• Lifecycle management of the stability programs, reference standards, and appropriate controls. • Lead the implementation of stability operations (stability protocol design and execution, interactions with partners and other collaborators • Collaborate cross-functionally with internal stakeholders and external organizations to streamline processes, implement improvements, and facilitate communication. • Coordinate timely delivery of stability results from CMOs required by CMC Regulatory groups, and for support of commercial manufacturing. • Assist and provide strategic guidance in stability-related investigations, deviations, CAPAs, temperature excursion determinations, quality and operational improvements, etc. to ensure continued compliance with regulations. • Organize scientific study review, interpret data, and draw reasonable conclusions. • Assist in the establishment of department operational plans, processes, strategies, goals, objectives and metrics in alignment with the Company’s strategic plans and global expansion. • Contribute to stability sections of IND/IMPD and NDA/BLA/MAA filings, as well as Annual Product Reports (APQRs), and Product Quality Reports (PQRs) for commercial products. • Lead improvement initiatives with Mayne and TESARO team • Lead routine OOS investigation meeting to help to closure of them • Lead for Stability Operations in Niraparib Capsules and Tablets program.

• Review and release of batches, Raw Materials and Finished Products (small • Molecules)• Coordination and point of contact for testing outside the company• Review and release of Stability Reports • Point of contact for customers and suppliers for QC issues and questions• Writing and revision of SOPs and Stability protocols• Improve of the systems related to lab• Supervision, coordination and schedule the work flow in the lab• Review and approve of Raw Material Specifications• Review and approve of Finished Product Specifications• Review and approve of Stability Testing Specifications • Conduct and writing of Deviations, OOS, CAPAS• Documentation of QIRs, OOS, Deviations• GMP trainer • Develop GMP systems in QC Lab• Participation in daily schedule meeting to support the current business and new projects• Actively attend to new projects meeting and help in the develop of new business• Worked in the implementation of new equipment• Established Kaizens, Recognition Program and evaluation system for QC Lab• Write up of method validation, method transfer and method verification protocols• Leader and supervision of method validations, method transfers and method verifications.• Established expiration for water storage based in storage validation• Established system for standard and mobile phases stability• Assist QA during FDA and customer audits• Coordination of installation and qualification of new equipment