Implemented servant leadership, strategic guidance, and expertise to pilot plant aseptics unit, in global, technical research and development. Drove optimal setup of GMP/non-GMP processes, assets, and operations, to support introduction of new chemical entities, biologics, and clinical supplies manufacturing for Phase 1/2 global trials. Increased operational efficiency, reduced costs, and accelerated product development. Ensured sustained over 95% plant KPIs.
• 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.

Oversaw 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. Submited 65 ideas, with 36 progressing to six sigma projects and simplification ideas.
• Organized Six Sigma basic training and achieved more than 90% of associates, in line unit, trained.
• Coached two Six Sigma Green Belt projects and two Six Sigma Yellow Belt Project certifications.
• Ensured achievement of KQI/KPIs for Fort Worth site and Global Pharmaceutical Line Unit.

Led strategy and overall CMC product development plan for global projects. Directed technical R&D team and represented technical R&D in key decision boards. Ensured budget and resource allocation and alignment with internal and external stakeholders and company's vision.
• 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 full initiation of Clinical trials.
• DPPL for ophthalmology projects for suspensions and solutions. Released 5 DP clinical batches. Filed provisional patent application (PAT059103-US-PSP).
• Oversaw a 10-person team.

Directed strategy and planning of all product development plan for global projects. Led DP Team and represented technical R&D in CMC team and governance processes. Ensured budget, contingency planning and risk assessment aligned with overall TRD project plan, SOPs and management strategy.
• Led effective technology transfer of two preservative-free projects from R&D to technical manufacturing operations (commercial) as planned.
• Oversaw overall plan for nanoemulsion DP formulation development, scale up, Design of Experiments (DOE), Quality by Design (QbD) and transfer to Tech Ops for registration stability batches manufacture ensuring meeting timelines and achieving US/EU launch. Prepared CTD and Technical File.
• Managed GLP tox supplies manufacture internally and externally at CROs and GMP clinical supplies manufacture internally and externally at CDMOs.
• Coached 4 Project Leads, two formulation and two analytical scientists, into DPPL role.

Led product support projects for surgical solutions, focused on Ophthalmic Viscoelastic Devices (OVDs) and irrigating Solutions. Achieved seamless collaboration as SPOC with TechOps Puurs (Belgium) for OVDs.
• Provided analytical support and CMC technical regulatory input to Health Authorities (HA) agencies, achieving 100% on-time delivery.
• Coordinated and updated RMRs with 100% renewed Life Cycle Management Analytical Chemistry Lead, Intraocular Lens (IOL) project
• Completed 3 method development to support biocompatibility testing.

Led concept ideas through ideation process to exploratory stage, presented and obtained governance approval.
• 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 prefilled syringe, exploratory stage.
• Approved three projects for dry eye and for retina detachment, exploratory stage.

Led CMC sub-team for exploratory project. Oversaw ideation team (6 scientists), for new sustained release platforms. Directed development of comprehensive research and development strategies.
• Completed modeling and simulation assessment and received special achievement award for excellent contribution to pre-formulation stage of Bradykinin Agonist.

Conducted pharmaceutical R&D of products for ophthalmic and optic application, from exploratory through product support. Created and implemented optimized processes and procedures.