Alex Goraltchouk Email & Phone Number

Needham, Massachusetts, Us

Responsible for the buildout and leadership of the Development, Operations, and Program Management teams at Remedium Bio. Overseeing development and scale-up activities for nucleic acid synthesis and plasmid/nano-plasmid/DNA-minicircle production to support pre-clinical studies and clinical trials. Responsible for the development and operationalization of lipid nanoparticle encapsulation processes and viral vector packaging (AAV, AV, LV), scale-up activities, and production of recombinant proteins. Leading assay and test method development, process ranging study design, and scale-up activities. Responsible for the preparation of all pre-clinical grade, clinical grade, and GMP material. Functionally responsible for Development, CMC, Operations (Manufacturing Sciences, Engineering, External Manufacturing, Supply Chain, Procurement), IT, and Program Management.

Bedford, Ma, Us

Led the Manufacturing, Supply Chain, Technical Operations / Engineering, Facilities, and EHS teams for a global supplier of pharmaceuticals, medical devices, and combination products (>800 products in >85 geographies). Responsible for capital projects, system implementations (ERP, EBR, WMS, BMS/BAS, MES, EHS), process development, automation, and operational excellence (Lean/6-Sigma/QBD). Responsible for drug substance, drug product (aseptic and terminally sterilized), medical device, and packaging production, planning, distribution, and strategy. Promoted to Senior Vice President after two years of service to additionally build and lead the Project Management Organization.

Aliso Viejo, Ca, Us

Developed and led the global supply chain (74 countries / 35 products / commercial and clinical), procurement, strategic sourcing, external and internal manufacturing, logistics, and technical operations functions for drug substance, drug product (aseptic filling), and medical devices (including capital equipment and single use products). Established the S&OP process, EH&S organization, advanced supply chain planning and business analytics tools, Electronic Batch Records, as well as 5S and Lean/6Sigma practices on all production lines. Led the team responsible for process development to supply clinical drug product including API, formulation, and the packaged drug product forms.

Cambridge, Ma, Us

Led the global pharmaceutical packaging, labelling, serialization, and medical device operations functions responsible for all technical aspects of the manufacturing process (internal and CMO). Led the drug product function as the Global Process Owner. Oversight for all internal, external, CMO, and partner manufacturing sites. Responsible for all aspects of industrialization, transfer, scale-up, validation, lean 6-sigma, launch, and commercial manufacturing. Oversight of all manufacturing process improvements, deviations, change controls, CAPAs, and investigations.

Tarrytown, New York, Us

Built and managed the Combination Products organization including all development, manufacturing, and quality engineering activities (quality system buildout, risk management, 21 CFR 820/4, ISO 13485). Promoted to build and lead the drug product (aseptic filling) and pharmaceutical packaging Technical Operations groups. Responsible for all development and industrialization projects, capital investments, facilities buildout, manufacturing line buildout, scale-up, supply agreement negotiation, launch activities, all technical aspects of regulatory submissions, interaction with inspectors and reviewers (EMA, MHRA, FDA). Promoted to build and lead the Drug Product Development group.

Dublin, Coolock, Ie

Built and managed the Histopathology, Metrology, Microscopy, and Molecular Cell Biology groups. Led the team through development of bioassays, quantitative immuno-histopathological test methods, and in vivo models. Supported the drafting of technical documents for all regulatory submissions (IND/IDE, NDA/BLA/510k/PMA, CBE30/PAS/AR). Promoted to lead the Formulation and Biomaterials team including all internal, partner, and contract research activities. Responsible for laboratory buildout and project management through GLP, biocompatibility, and PK/PD/tox studies. Promoted to build and lead the Formulation, Drug Delivery, and Biomaterials development group.

Westwood, Massachusetts, Us

Led discovery, innovation, and development teams for new therapeutics, medical devices, and combination products. Specific project focus on Drug Eluting Stents, Therapeutic Formulations for Proliferation and Adhesion Prevention, Anti-Infective Catheters, Quill Barbed Suture, and AAA Stent-Grafts. Promoted to lead project teams within a year of hire. Responsible for API selection, formulation, dry/liquid/gel compounding, coating, pilot scale development and automation, preparation of systems for compliance with FDA 210/211/820, ISO 13485/14644/10993, PMA, and CE mark audits.

Masc, Master Of Applied Science And Engineering, Chemical And Biomedical Engineering

Basc, Bachelor Of Applied Science And Engineering, Materials Engineering

Master Of Science - Ms, Finance

Master Of Business Administration - Mba, Management

Master Of Science - Ms, Microbiology And Cell Science (Conc. Medical Microbiology And Biochemistry)