Nuria Jimenez, Phd, Pmp Email & Phone Number

Dallas, Texas, United States

Fort Worth, Texas, United States

• Implemented servant leadership, strategic guidance, and expertise to the Pilot Plant Aseptics Unit in Global Technical Research Development; driving the optimal setup of GMP/non-GMP processes, assets, and operations to.
• Implemented new product introduction process and long-term strategic capacity/capability planning. Evaluated 15 projects/3 platforms with 8 deemed a good fit and implemented them within 12 months.
• Oversight of third parties, managing a portfolio of over 40 vendors ensuring adherence to business and quality standards with over 95% vendor compliance rate and consistently delivering on project milestones.
• Managed a team of over 20 indirect reports.

Fort Worth, Texas, United States

• Led the strategy and overall product development plan for global projects; effectively directed Technical R&D Team and represented Technical R&D in key decision boards ensuring budget/resource allocation and alignment.
• TPL/SPOC for cell and gene therapy (CGT) support projects for ophthalmology and hematology. Successful oversight of development, external manufacturing and release of 4 DP clinical batches (RNA) ensuring on time in.
• DPPL for Ophthalmology projects for suspensions and solutions. Successful release of 5 DP clinical batches. Filed Provisional Patent Application (PAT059103-US-PSP).
• Managed a team of 10 indirect reports.

Fort Worth, Texas, United States

• Directed strategy and planning of all product development activities for global projects; led DP Team and represented Technical R&D Subteam in CMC Team and governance processes. Ensured budget, contingency planning and.
• Effective technology transfer of 2 preservative free projects from R&D Fort Worth to Technical Manufacturing Operations (Tech Ops) in Puurs, Belgium.
• Successfully managed a nanoemulsion DP formulation development, scale up, Design of Experiments (DOE), Quality by Design (QbD) and transfer to Tech Ops for Registration Stability batches manufacture. Achieved EU/US.
• Coached 4 Project Leads, two formulation and two analytical, into DPPL role

Fort Worth, Texas, United States

• Managed CI portfolio in Global Pharmaceutical Development Line Unit (LU), ensured productivity savings and compliance.
• Designed a tool to collect, assess and prioritize CI ideas at TRD level. Submitted 65 ideas, with 36 progressing to six sigma projects and simplification ideas.
• Organized Six Sigma basic training and achieved more than 90% of associates trained.
• Coached 2 Six Sigma Green Belt Projects and 2 Six Sigma Yellow Belt Project certifications.
• Ensured achievement of KQI/KPIs for the Fort Worth Site and Global Pharmaceutical Line Unit.

• Managed Product Support projects for Surgical Solutions, focusing on Ophthalmic Viscoelastic Devices (OVDs) and Irrigating Solutions; achieved seamless collaboration as SPOC with TechOps Puurs (Belgium) for OVDs.
• Provided analytical support and technical regulatory input to agencies, achieving 100% on-time delivery.
• Coordinated and updated RMRs with 100% renewed Life Cycle Management.Analytical Chemistry Lead in Intraocular Lens (IOL) Project
• Completed 3 method development to support biocompatibility testing

Fort Worth, Texas, United States

• Led concept ideas through the Ideation process to Exploratory Stage, presenting and getting approval from governance.
• Assessed new technologies to establish proprietary position.
• Designed pharma-IOL approach for Post-Cataract Opacification Prevention, Ideation Stage project.
• Approved strategy of an antibiotic for intracameral injection after cataract surgery using a prefilled syringe, Exploratory Stage.
• Approved 3 projects for dry eye and for retina detachment, Exploratory stage.

Fort Worth, Texas, United States

• Led CMC Sub Team for Exploratory project. Managed Ideation Team (supervised 6 scientists) for new sustained release platforms. Directed development of comprehensive research and development strategies.
• Successfully completed modeling and simulation assessment. Received Alcon Special Achievement Award for excellent contribution to Preformulation Stage of Bradykinin Agonist.

Barcelona, Spain

• Conducted pharmaceutical R&D of new products for ophthalmic and otic application from Exploratory through Product Support. Created and implemented optimized processes and procedures.
• Developed new drug delivery formulations (nanoparticles, microspheres, microaggregates, nanosuspensions, cyclodextrin complex suspensions).
• Served as Formulator for liquid, solid and semisolid dosage forms in full development projects from Exploratory through Product Support including extemporaneous solution filled in bicompartimental packaging to.
• Prepared and reviewed CMC sections for IND, NDA, MAA, CE Technical file. o Participated in 6 projects that advanced to POC o Contributor on launch of 5 Alcon marketed products

Phd, Pharmaceutical Science, Physical Chemistry, Graduated Cum Laude

Activities and Societies: Stabilization of Proteolytic Enzymes for Otic and Ocular Application

Msc, Nutrition And Food Technoloy

Activities and Societies: Foam Prediction of Sparkling White Wines.

Bachelor Of Pharmacy - Bpharm, Industrial Pharmaceutical Technology