Eli Hoory Email & Phone Number

Boston, MA, US

Boston, MA, US

• Strategic and Technical PIP leading technology transfer/PV activities to enable new continuous manufacturing (CM) capabilities at external CMO
• Possession of leadership competencies including CMO relationship management - influencing with persuasion; day to day point of contact
• Application of continuous improvement initiatives across spray drying and continuous manufacturing platforms at multiple sites
• Resolution of complex commercial manufacturing issues with mindfulness on supply, quality and regulatory constraints

Boston, MA, US

• Leading technology transfer activities to enable new continuous manufacturing (CM) capabilities at external suppliers to increase business capacity
• Authoring/review of regulatory filing activities such as criticality analysis, and regulatory leafs including P2.3 Intro to CM, P2.3 Manufacturing process development – tablet
• Fluency with QbD concepts and process model development tools
• Representing Tech Ops on cross-functional CMC subteams, to influence late stage process/product development and minimize subsequent commercialization risk
• Day-to-day point of contact with contract manufacturing partners; representing TechnicalOperations on working teams
• Mentoring of Technical Operations staff to support ongoing commercial manufacturing

Bridgewater, New Jersey, US

• Experience in process development, technology transfer, scale-up, product launch for solid oral dosage forms
• Managed and mentored process team of direct reports to fulfill scale-up/production requirements on schedule for pivotal and ANDA batches
• Lead morning R&D group meetings on daily basis to discuss production results, issues and strategy moving forward
• Manage Daily, weekly and monthly key metrics and data generation and reporting process
• Responsible for allocation of resources for all pre-planned R&D projects within production
• Initiated and implemented streamlining measures/continuous improvements within group and together with Cross functional departments

US

• Providing technical support (process development, process validation, product and process troubleshooting, process and product optimization, and technical transfer) of commercialized products.
• Team Leader in successfully implementing company’s first Continued Process Verification (CPV) Baseline assessment for OTC products (including development, training, execution, statistical assessment and protocol/report.
• Managing and executing projects tasks per established timelines
• Prepare, report, summarize data and recommend conclusions based on scientific rationale
• Design methods to efficiently carry out planned experimentation and execute requirements of the planned experimental design (i.e. sample collection, in-process testing, sample management)
• Manage change control deliverables and documentation

Melville, New York, US

• Responsible for determining validation needs and developing and reviewing IQ/OQ/PQ protocols and reports for manufacturing processes and equipment.
• Involved in engineering optimization studies by providing technical support to improve efficiency and reliability for packaging equipment.
• Assist in the execution of protocols and the review of all data.
• Assist in the development and/or improvement of SOP’s within the Validation Department.

Hauppauge, New York, US

• Part of a Group that implemented a successful Validation Program in compliance with current regulations and cGMP thereby remediating deficiencies and leading to the subsequent lifting of an FDA warning letter.
• Conducted gap assessments on OTC and RX products including historical reviews and retrospective validations and updated SOP’s to reflect cGMP.
• Authored and reviewed multiple validation protocols and reports (individual manufacturing stage to full manufacturing process).
• Provided evaluation and interpretation of data by statistical analysis (CPK, ANOVA).
• Wrote multiple R&D challenge study protocols and reports that evaluated equipment performance during the manufacture of pharmaceutical products.
• Team leader in developing R&D protocols and writing reports for Bulk Hold-Time Studies assessing tablet/capsule purity and dosage strength.

• Technician for mechanical testing: tensile, proof load, compression, shear, fastener, and bend tests (primarily for aerospace industry)
• Conducted Hardness testing (Brinell and Rockwell)
• Provided Metallurgical evaluation including Knoop, Vickers analysis, Corrosion, Conductivity, Case depth/decarburization and Intergranular attack
• Developed spreadsheets for statistical analysis
• Responsibilities included that of quality control and maintenance

Port Washington, New York, US

• Primary analyst in the development and optimization of Blood/Plasma separation techniques using filter membranes (resulted in the development of company product)
• Helped develop and optimize protocols for lateral flow immunoassay studies (Abstract and poster of work published in AACC 2008)
• Wrote scientific lab procedures (SOP’s) and performed validation testing
• Conducted quantification tests on cells to determine viability (ATP assay)
• Conducted quantitative colorimetric assays; ELISA
• Performed multiple projects at a time; exceeded expectations

Port Washington, New York, US

• Strong analytical skills and bench-top experience
• Assembled numerous filtration systems and analyzed filters for compatibility and characterization studies
• Primary analyst for tensile testing on various polymeric materials for aging and chemical compatibility studies
• Provided training on filtration systems used in Biopharmaceuticals for sales representatives
• Conducted extractable testing for validation studies including following types of analysis: - Fourier Transform Infrared Spectroscopy Analysis (FTIR); characterization - High Pressure Liquid Chromatography (HPLC).

Stony Brook, NY, US

• Development of PCR programs and use of PCR technique to amplify genomic DNA
• Proficient with Agarose Gel Electrophoresis techniques- Preparation of gels of various concentrations- DNA loading and recovery from gels- Analysis of DNA with pulse-fields
• Polymer Thin Film Preparation, Deposition, and Characterization- Preparation: Polymer dissolution and silicon wafer cleaning to remove organic contaminants- Deposition: Polymer adsorption via spin cast.