Phil Estepa

About Phil Estepa

PROFESSIONAL SUMMARYCombination Products ~ Global Medical Device Development ~ Pharmaceutical Drug Delivery Systems ~ Regulatory Requirements ~ Global Device Strategy and Business Partnerships Goal-oriented professional with vast experience in combination products / medical device development and manufacturing, with expertise in leading domestic and international device development programs. Successfully launched several commercial products, overseeing the full product life cycle from concept to commercialization. Well-versed FDA Design Controls, GMP’s and EU Medical Device Directive. Proficient in Cross Functional Leadership & Leading Projects.HIGHLIGHTED SKILLS* Successfully developed and commercialized multiple combination products currently in the market.* Global experience (US, Asia & EU) in medical device industry in design, development, validation and commercialization of multiple Combination Products, Class cardiovascular/neurological devices, drug delivery devices and implants (cardiac stents) from R&D to Commercialization.* Senior Management Professional involved in various technical assignments, directing programs in product and process development cycle, from the R&D/Clinical, and initial concept stage to Manufacturing.*Lead oversight and interaction with world-wide contract suppliers/OEMs during the development, manufacturing, filling and packaging of the drug-device combination, including pre-filled syringes & dual chamber container closures in multiple global regions (US, EU, Asia & Middle East)*Initiated and completed multiple cleanroom production lines, validating cleanrooms, technical transfer and starting full-scale manufacturing for start-up companies, European satellite facilities and Mexico Maquiladora operations.* Experience in a FDA-QSR & GMP regulated medical device & combination products environment, knowledgeable of FDA design controls, assisting in multiple product submissions to FDA (NDA, IDE, 510k & PMA) and European Medicines Agency (EMA)* U.S. Patent No. 70•••37, U.S. Patent Application Publication No. US 2010/02•••68 A1, International Patent Application Publication No. W0/20••••••39 A1* Successful Development and Commercial Combination Products: Symlin Pen, Byetta Pen, Bydureon Kit, Bydureon Pen, Bydureon BCise Autoinjector, Vitaros Prefilled Syringe, Auvi-Q Autoinjector, Evzio Autoinjector, Gvoke Prefilled Syringe, Gvoke HypoPen Autoinjector, Gvoke Kit, Gvoke Diagnostic, Wainua Autoinjector, Tryngolza Autoinjector and just approved Dawnzera Autoinjector!

Experience

1. Executive Director, Pharmaceutical Development (Combination Products)

   Ionis Pharmaceuticals, Inc.

   Oct 2021 — Present · Carlsbad, CA, US

   Oversee, build and lead the drug delivery device development team tasked with global strategy of developing and commercializing multiple autoinjector/PFS programs, inhalation, and other delivery devices as needed.*Management of Alliance Partners in the development of multiple combination products.*Late stage development and commercialization of Antisense Oligonucleotide therapies in combination product format, which are designed to interact precisely with RNA, allowing us to create treatments that disrupt the disease process and change its course.

Education

• UC San Diego

  Certificate, Biomedical Manufacturing

• San Diego State University

  Bachelors, Industrial Technology, Plastics Development

Skills

• R&D
• Quality System
• V&V
• Product Development
• Technology Transfer
• Iso 11608
• Process Simulation
• 21 Cfr Part 11
• Analytical Chemistry
• Sterilization
• Regulatory Affairs
• Lifesciences
• Design Control
• Design of Experiments
• Manufacturing
• Hplc
• Biotechnology
• Process Engineering
• Iso
• Pharmaceutical Industry
• Sop
• Biopharmaceuticals
• Fda
• Drug Delivery
• Lims
• Clinical Trials
• Cleaning Validation
• Change Control
• Gamp
• Lean Manufacturing
• Cross-Functional Team Leadership
• Iso 14971
• Spc
• Commercialization
• Calibration
• Medical Devices
• Capa
• Quality Control
• Gmp
• Root Cause Analysis