Elana Gazal

Built a multidisciplinary R&D organization of 20 scientists across multiple program lines, delivering the company’s regenerative-medicine platform for tissue regeneration, 3D-bioprinting bioinks, and aesthetic-medicine implants. Advancing novel biomaterials from early research into preclinical development, defining and executing the product and portfolio strategy, and managing major scientific and clinical partnerships. Accelerating time-to-market and ensured rigorous design control, risk management, and regulatory alignment. Managing budgets, timelines, CRO, prioritization, and problem resolution across programs. Providing strategic scientific leadership, guiding innovation from concept to preclinical and clinical readiness, and communicated strategy, risks, and progress to executive leadership and the board. Leading the first successful bioprinted clinical-size implant and positioned the company as a leader in regenerative breast and soft-tissue technologies

Directed a team of 5 members - Led drug device combination development – submitted to the FDA and EU Led pharmaceutical development for subcutaneous and transdermal drug products, managing all chemical, analytical and formulation activities from early research through NDA submission. Oversaw program planning, budgeting, timelines and global cross-functional execution. Directed GMP manufacturing and GLP preclinical support, impurity synthesis and qualification, and guideline alignment. Designed NCEs synthesis and formulation development. Led studies across early- and late-stage development and supported QA, CMC and RA teams.

Led internal and external chemistry related activities (synthesis, purification and characterization) (NMR, MS, IR, HPLC, KF etc) Collaborated with CMC and CROs to support synthesis activities Wrote and reviewed study results, protocols and reports

Waters designs, manufactures, sells and services ultra performance liquid chromatography (UPLC), high performance liquid chromatography (HPLC), chromatography columns and chemistry products , mass spectrometry (MS) systems and software solutions Worked with Israel top Pharma and Biopharma companies R&D and QC HPLC and Empower software Method development, support and troubleshooting of various applications Regulatory and Compliance and 21 CFR part 11 on Empower

Led project from development to clinical trials Multitasking several projects and plans; Established program plans, budgeting and timelines Collaboration with leading pharma companies Supported clinical studies – submission to local IRB committees

Method development and troubleshooting (USP/EP) for unique pharmaceutical platforms topical and cosmetic formulations (HPLC, MS) Method validation and SOP writing Development of unique pharmaceutical platforms – topical, oral and vaginal foams, ointments and lotions Supported manufacturing for first in men clinical trials Wrote procedures and MBRs; Collaborated with external CMOs and CROs

Project manager: managing a team of 10-15 development scientists; Established budget and resources management; Drafting program plans and development projects; Work closely with Manufacturing to transfer products Presented data and research findings at departmental meetings and to upper management Represented development in a core team of Marketing, Regulatory, MFG, Clinicals; Supported FDA submissions and review of Clinical data

Assay developer: development of immunoassays for the “Access” family platforms. Independently designed and implemented experimental strategies utilizing skills in organic chemistry and biochemistry. Optimization and troubleshooting of current products. Developed cross linking methods Orientation and training new staff.

Developed and implemented methods for separation, stability evaluation and kinetic studies of pharmaceutical peptides and small molecules using HPLC-PDA and MS. Kinetic studies and stability assessment were carried out using a variety of parameters e.g. temperature, pH, solvent and storage effects

Undergraduate Organic Chemistry class. Undergraduate Analytical Chemistry laboratory. Planned courses, coordinated materials, conducted lab sessions and graded lab reports and exams.

Designed and synthesized antibacterial peptides and multiple peptide libraries using Solid Phase Peptide Synthesis for inflammatory uses. The libraries were screened by high-trough-put screening assays and the data obtained was employed for design and synthesis of 2nd and 3rd generation libraries. Developed analysis and purification methods for HPLC.

Specialized in analysis, separation and quantification of drugs and medications from biological fluids by using a variety of methods, including RIA, HPLC, EMIT and GC-MS.