Daniel Ortega Email & Phone Number

San Antonio, TX, US

Austin, Texas, US

I am currently Senior Director of Drug Development and Production for PLUS Therapeutics. Throughout the 17 years of my career, I have had the privilege of developing CMC strategies for pharmaceutical development programs and technology transfers with extensive experience in small molecule drug products and radiopharmaceuticals. I have extensive knowledge.

Austin, Texas, US

San Diego, CA, US

• Results driven and detailed oriented professional with experience in working in a pharmaceutical company with multiple product types and regulatory agencies. background in understanding EMA, FDA, and ICH requirements.
• Responsible for the integration, creation and execution of multiple complex Chemistry/Manufacturing/Controls (CMC) drug development programs for generic and proprietary liposomal drug products through Phase I through.
• Prepare all regulatory documentation and communication within and outside of the organization. Interface with FDA and EMA division personnel to present pre-IND and IND packages.
• Oversight of all R&D and manufacturing resourcing, planning, budgeting and execution. Temporary site head for QA department.
• Provide necessary program direction for planning, organizing, developing and integrating project across multiple functional groups.
• Develop and maintain fully integrated project plans to ensure that deliverables are successfully executed, are in accordance with project and disease area objectives, and are within budget.

San Diego, CA, US

US

• Responsible for project management activities associated with the development and FDA approval of New Drugs (NDAs), generics (ANDAs), technology transfers, and product site transfers.
• Work directly with client-side Project managers to develop, write and process work orders as part of the Request For Proposal (RFP) process.
• Develop and manage cross functional teams between clients, science and manufacturing teams to drive project and process solutions.
• Manage client communications, visits and audits with support of corresponding internal departments.
• Prepare and present monthly/quarterly (or as required) project updates to executive management and external clients.
• Seek additional business opportunities with house accounts.

US

Responsible for sustaining business growth. Establish new business relationships within the pharmaceutical and manufacturing industry. Maintain current customer relationships and ensure customer loyalty. Define new market opportunities that satisfy customer needs by researching industry trends. Implement new policies and procedures to meet industry standards

Responsible for leading, designing and implementation of process development projects; manage project resource allocation; provide product development direction and technical support for existing and potential clients; design process development and scale up activities; coordinate manufacturing support activities with QA/QE;Maintains and enforces cGMP.

Responsible for developing innovative drug delivery systems, and new drug applications for current and future clients; provide customer service by presenting ideas for modifying existing procedures and suggest alternative methods to improve results; work closely with internal and external departments to ensure efficient progression of projects; provide.

Outside Sales

Master Of Business Administration - Mba, Business Administration And Management, General

Bachelor'S Degree, Biology/Biological Sciences, General

Master Of Business Administration - Mba