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 in drug design, product formulation, design of experiments, process characterization, process optimization, method validation, and continuous improvement, as well as a strong background in understanding FDA, ICH, and other regulatory requirements through all phases of development and post-approval. My experience in establishing strong relationships with internal and external partners, contracting, and monitoring external CMOs, and defining and managing CMC program budgets, have enabled me to be successful in completing pharmaceutical development programs. I have developed and implemented processes for evaluating the performance of CMOs, including regular site visits and assessments of their quality systems, regulatory compliance, and a monitoring program. In addition, I have expertise in identifying, selecting, reviewing, and finalizing contracts and supply agreements with external partners to ensure a long-term supply chain. This includes working closely with legal teams to negotiate and finalize contractual terms and conditions that are favorable to our organization, while ensuring compliance with regulatory requirements. As a leader, I am experienced in leading cross-functional teams, change management, and defining future-state solutions to achieve corporate goals. I have defined strategic plans and led execution and implementation of CMC program plans from process development to commercial launch in collaboration with leadership and cross-functional teams. I have designed process characterization and optimization studies for drug substances and drug products and designed a continuous improvement.

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 through drug development and post approval product life cycle for semisolids, parenterals , and liposomes. Proven ability to effectively manage multiple projects and nationwide cross functional teams. An energetic leader with a focus on developing strong teams that continuously exceed goals and solve complex challenges.• 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 commercialization. • 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.• Oversee the CMO’s manufacturing, sterile fill/finish and analytical activities related to internal drug development programs. • Responsible for comprehensive communication, including status reporting, risk management and escalation of issues to cross-functional stakeholders and Senior Management. • Evaluate potential new drug technology and business opportunities.

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 guidelines; calibration and preventive maintenance for all manufacturing equipment; manage laboratory inventory and laboratory budget.

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 scientific, technical and process development assistance to commercial and new products; supervise and support the manufacturing of batches at the manufacturing site from R&D stage through Process Validation; coordinating the approval of manufacturing batch records; coordinate supportability for manufacturing, testing and development of products with clients and the project management team.

Outside Sales

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

Bachelor'S Degree, Biology/Biological Sciences, General

Master Of Business Administration - Mba