Nick J. Manesis, Phd Email & Phone Number

Product development.

• PRODUCT AREA: Custom silicone formulations.INDUSTRY: Biomedical device | multiple healthcare areas (wound healing, medical aesthetics, tissue scaffolding, cell culture).KEYWORDS: Open-cell silicone foam | wettable |.
• Founded early-stage business engaged in building out technology platform based on open-cell porous structures for healthcare applications.
• Licensing Agreement finalized with healthcare company per specific fields of use.
• Lead inventor on composition, process of manufacture, and method-of-use PCT patent applications.
• Strong IP position covering composition-of-matter, method-of-manufacture, and method-of-use applications. U.S. and PCT applications filed.
• Developed composition and method-of-manufacture.

• PRODUCT AREA: Spinal injection for relief of lower back pain.INDUSTRY: Medical device | orthopedics (spine).RESPONSIBILITIES & ACCOMPLISHMENTS:
• Active member of cross-functional international team responsible for key elements within R & D, manufacturing, clinical research, regulatory affairs, intellectual property, and investor outreach.
• Managed pre-clinical activities including product development, scale-up manufacturing, animal studies, ISO 10993 biocompatibility tests. Generated documentation for design control, DHF, Design Dossier, and technical.
• Managed safety and performance activities. Developed R & D strategy involving biomaterial formulation, characterization and bio-simulation testing. Managed animal study protocol, explantation, and histopathology..
• Developed injection composition based on hyaluronic acid (HA) and acrylic microspheres. Optimized material for extrusion through 22 G needle. Set biological, chemical, and physical specs for incoming raw material and.
• Managed supply chain. Conducting sourcing and qualification of raw materials. Managed finished product activities within contract manufacturer.

• PRODUCT AREA: Corneal implant for treatment of presbyopia, pharma eye drops for presbyopia.INDUSTRY: Medical device | pharmaceutical | ophthalmic.STAFF: 6 employees, 4 consultants.BUDGET(ANNUAL): $2.5M.
• Managed interdisciplinary team: design & mechanical engineers, material & analytical scientists, medical affairs, clinicians, practitioners, and optical engineering.
• Developed fully biocompatible corneal implant without use of steroid anti-inflammatories. 3-Year animal implants no inflammation with no degradation.
• Managed in-licensing of pilocarpine-based formulation for presbyopia. Conducted formulation vs efficacy studies. Responsible for CMC activities.
• Engaged in technical marketing, IP portfolio, and regulatory support. Interfaced with KOL’s, practitioners, and academicians.
• Built Operations infrastructure from scratch. Areas included: lab and clean room design & build-out, materials development, fabrication, scale-up and manufacturing lines, QC, and clinical supplies.

Dublin, Coolock, IE

• PRODUCT AREA: Dermal filler, breast implants, tissue expander, gastric.INDUSTRY: Medical device | combination products | medical aesthetics.STAFF: 24 employees U.S., 28 employees international.BUDGET(ANNUAL): $15M.
• Provided leadership & management of U.S. and international functional teams totaling 52 persons.
• Created Materials Development & Analytical Services functions from the ground up. Created infrastructure including staffing, lab build-out, and systems & procedures. Capabilities were showcased throughout entire pharma.
• Delivered performance-oriented product attributes by effectively integrating material science, engineering, and analytical activities in the development of medical aesthetics products.
• Managed yearly budgets up to $15M USD with targeted variance less than 3% quarter-to-quarter.
• Spearheaded knowledge transfer, expertise, and analytical capabilities across multiple departments within both device and pharma communities.

San Ramon, California, US

• PRODUCT AREA: Contact lens.INDUSTRY: Medical device. Ophthalmics.STAFF: 25 employees U.S.BUDGET(ANNUAL): $6M USD.RESPONSIBILITIES & ACCOMPLISHMENTS:
• Developed strategy and managed material development activities for multiple projects: daily-wear Avaira™ silicone lens product, low- cost silicone daily disposable product, cost reduction of the existing Biofinity™.
• Responsible for establishing Materials Development and Analytical Testing infrastructure. Interfaced with manufacturing and QA to ensure proper technology transfer and design control documentation.
• Instrumental in developing and implementing strategy for developing the first silicone hydrogel contact lens product on CooperVision’s existing manufacturing platform. Interfaced with chemical suppliers targeting.
• Managed internal staff of 25 scientists and process engineers and supported international teams of up to 30 persons within UK and Puerto Rico R & D, Quality, and Manufacturing areas.

PRODUCT AREA: Preservative-free packaging, eye drops.INDUSTRY: Packaging, ophthalmic

Palo Alto, CA, US

PRODUCT AREAS: Inkjet media products, small & large format.INDUSTRY: Electronic printing.

PRODUCT AREAS: Contact lens.INDUSTRY: Medical device. Ophthalmic

PRODUCT AREAS: Corneal implant, epikeratophakia.INDUSTRY: Medical device. Ophthalmic.

La Jolla, CA, US

Thesis title: "Synthesis and Conformational Analysis of beta-Turns as Model Systems for Proteins." Advisor: Dr. Murray Goodman.

Albuquerque, NM, US

Supported research programs in the areas of solar energy and combustion.

Doctor Of Philosophy - Phd, Chemistry

Ph. D., Chemistry

Doctor Of Philosophy - Phd, Chemistry

M.S., Chemistry

B.S., Chemistry

B.S., Biology

Doctor Of Philosophy - Phd, Chemistry

Doctor Of Philosophy - Phd, Chemistry