Vice President Product Development
OCULAR THERAPEUTIX, INC is a pharmaceutical company which specializes in ocular drug delivery, surgical sealants, sustained delivery, ophthalmic therapies, ophthalmology.
Extensive R&D experience in drug delivery, biomaterial, pharmaceutical, and medical device development and technology portfolio management; working within both start-up and large company environments. This includes a strong record of transforming innovative concepts into commercial products that address unmet clinical needs. Possess a diverse clinical experience across numerous specialties and indications. Project and organizational leadership by building and developing teams and creating and executing product and process development systems. Specialties: R&D, product development, research, technology development, specialty pharmaceuticals, biotechnology, medical devices, drug delivery, sustained release, combination device, biosurgery, biomaterials, proteins, anti-VEGF, steroids, tki, antibiotics, ocular, ophthalmic, glaucoma, dry eye, allergy, retina, AMD, DME, neurosurgery, spine, vascular, thoracic, GYN, GI, interventional, catheter, venous access, sealant, adhesion barrier, hemostat, adhesive, hydrogel, biologic, microsphere, microparticles, encapsulation, depot, insert, implant, PMA, NDA, 505b2, ANDA, 510k, EMA, MAA, CE Mark, class III, IDE, IND, FDA panel , Shonin, design control, chemistry manufacturing and controls (CMC), target product profile (TPP), critical process parameters (CPP), critical material attribute (CMA), Design of Experiments (DoE), quality by design (QbD), risk analysis, module 3 drug substance & drug product, module 4 non-clincial, pharm / tox, pre-clinical, clinical evidence, project management, portfolio management, Form S-1, IPO, pre approval inspeciton (PAI), common technical document (CTD, eCTD), ISO 13485, FDA QSR 21 CFR 820, ICH, current good manufacturing practices (cGMP, GLP)
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