Becky Triantos Email & Phone Number

San Mateo, Ca, Us

Supports end-to-end clinical supply responsibilities to ensure on-time delivery and continuity of clinical supplies to global clinical sites.

South San Francisco, California, United States

South San Francisco, California, United States

The Manufacturing Process Coordinator supports Catalyst’s Drug Product operations through execution or oversight during GxP manufacturing of biologics drug products (formulation, fill, finish, packaging, labeling, and supply). • Develop, maintain, and improve GxP policies and procedures to ensure biologics drug product manufacturing is conducted in accordance with appropriate regulations, guidelines, and procedures. • Interact with the manufacturing and supply chain units of contract organizations or vendors to ensure that Catalyst’s interests are met while relationships are maintained.• Provide technical support, including planning, scheduling, risk management, and execution, to ensure requirements are met for biologics drug products (formulation, fill, finish, packaging, labeling, and supply) during: - Coordination of contracts for contract organizations- Manufacturing operations, including risk management, change management, deviation management, testing, batch review, metrics, and continuous improvement opportunities

South San Francisco, California, United States

• Partner across the business to ensure effective development, management, execution, and continuous improvement of Biologics Development and Manufacturing departmental business systems.• Develop working relationships and work collaboratively with internal stakeholders (e.g., Regulatory Affairs, Quality Assurance, Project Management, and Clinical Operations)• Provide technical support, including planning, scheduling, risk management, and execution, to ensure requirements are met for biologics drug products (formulation, fill, finish, packaging, labeling, and supply) during: o Coordination of contracts for contract organizations o Manufacturing operations, including risk management, change management, deviation management, testing, batch review, metrics, and continuous improvement opportunities• Coordinate relationships with drug product contract organizations and vendors, including communication and execution oversight, to ensure timely delivery of GxP products

Menlo Park, California

Dermira was acquired by Eli Lilly in 2020.Technical Writer (40-60% of time)• Partner with document owners to revise prioritized documents, providing authoring, editing and / or consulting services (such as feedback on training materials created from documents)• Manage document change process from change initiation through approval in Veeva, Dermira’s electronic document management system (EDMS)• Update and apply document standards (e.g. consistent application of definitions, level of detail required in SOPs, etc.)Project Leader (40-50% of time)• Drive critical Quality initiatives, working closely with sponsor to ensure alignment and secure resources• Define work breakdown structure and subsequent workstream approach based on initiative scope• Provide visibility to progress and highlight issues to resolve

Foster City, California

• Process documents and change requests/change controls in D2 Documentum EMDS and Veeva QDMS. • Review pharmaceutical development and manufacturing documents for proper grammar, mechanics, usage, style, and controlled template adherence (operating procedures, work instructions, user manuals, forms, commercial packaging & labeling, protocols, validation reports, references, training materials, templates).• Address 20+ urgent questions and requests per day from internal Gilead customers via the Document Control group email inbox. • Participate in cross-departmental meetings (e.g., Technical Writing, Laboratory Information Systems, Analytical Operations) to improve document consistency and quality.• Troubleshoot and propose solutions to internal Gilead customer issues to supervisors at team meetings. • Participate in ongoing training for skill development (CAPAs, deviations, technical writing, GxP best practices). • Update Quality Operations tracking spreadsheets.

Santa Clara, Ca

California Native and Exotic Grassland Research with Dr. Brody Sandel for Marin County.• Data collection in Marin headlands• Proficiency with ImageJ for image analysis• Experience with R Program for statistical analysis and graph creationMarine Intertidal Diversity Research with Dr. Dawn Hart• Data collection on coastal intertidal habitats in Santa Cruz, Monterey, and Soberanes• Skills include experimental design, data collection and verification, data analysis with graph creation and data interpretation • Proficiency with Excel, Word, and JMP programs