Sr. Analyst, Biologics Analytical Development @ Allergan
Consultant, International Expansion @ HeadBlade, Inc.
BS, Biology, Minor in Management @
University of California, Irvine
Passionate and highly motivated global regulatory affairs professional with over six years of experience in the pharmaceutical industry. Interested in obtaining a position with growth potential and which leverages my analytical background. Recently finished my MBA degree program at Pepperdine University. Experience in several different areas in the pharmaceutical industry including IT, operations/logistics, analytical development, and regulatory
Passionate and highly motivated global regulatory affairs professional with over six years of experience in the pharmaceutical industry. Interested in obtaining a position with growth potential and which leverages my analytical background. Recently finished my MBA degree program at Pepperdine University. Experience in several different areas in the pharmaceutical industry including IT, operations/logistics, analytical development, and regulatory affairs. Currently working at Allergan in Global Regulatory Affairs (CMC).
Specialist, Global Regulatory Affairs @ Manages global regulatory aspects of change control and compliance activities. Complies and submits post approval regulatory documents that meet global regulatory requirements. Responds to regulatory authorities questions with strict deadlines. Maintains regulatory files in a format consistent with requirements. Manages regulatory activities relating to a specific portfolio of ophthalmic and biologics products on a global scale.
• Ensures regulatory compliance for several cosmetic and therapeutic products
• Regulatory project lead for the company’s flagship product BOTOX®, providing project support including authorship, review and submission of new global registrations, authoring of product renewals and FDA annual reports
• Manages portfolio of ophthalmic solutions including beta blockers, NSAIDs, and anti-infectives
• Experience with NDA’s, BLA’s, Premarket Notifications [510(k)], and drug/plasma master files
• Regulatory SME for several regulatory electronic management systems including:
-Document management system (First Doc)
-Submission tracking system (RAPID)
-Filing sharing system (Microsoft Sharepoint)
• Manages post-approval changes related to product life cycle changes
• Works cross-functionally with QA, procurement, R&D, manufacturing, and other departments as necessary to ensure quality and completeness of submissions.
• Interpretation of compliance requirements of global health regulations and standards
• Creates regulatory strategies which provide the most optimal cost/compliance benefit to the company From 2013 to Present (2 years) Sr. Analyst, Biologics Analytical Development @ Provided characterization and formulation support on biological reagents based on research and self created methodology. Works on independent and team based projects with regards to developing experimental plans, executing experiments, and writing the corresponding reports and documents.
• Provides characterization and formulation support for several different molecules
• Versed in several different analytical techniques including:
-Various chromatography techniques (size exclusion, cation exchange, rp-HPLC)
-Subvisible Particle Analysis: (nano-imaging, dynamic light scattering (DLS), micro-flow imaging (MFI)
-Differential Scanning Calorimetry (DSC)
-UV, pH analysis
• Author of several reports and standard operating procedures used by the department
• Safety team lead for the characterization group
• Analysis of in-process-samples for the process development group
• Creating and presenting of scientific data to senior management
• Enrolled in QbD practitioner certificate program which included courses in:
-Engineering Statisics and Data Analysis
-CQA and VOC
-Quality Risk Management and FMEA
-Root Cause Analysis and CAPA
-Design of Experiments From 2010 to 2013 (3 years) Consultant, International Expansion @ Conducted a comprehensive market study to define the market opportunity for expansion into Europe. Developed and presented a formal marketing plan for initial expansion into Germany. Traveled internationally to access opportunities for expansion, overseas manufacturing, and distribution. Provided an analysis of domestic marketing opportunities in the Los Angeles area. This consulting opportunity was commissioned by the Pepperdine Education to Business program.
• Provided a country analysis of the European economic, industrial and political climate
• Provided an analysis of the European consumer good market
• Provided financial information with regards to potential expansion in several European markets
• Established several contacts in both the international and domestic market places From January 2012 to June 2012 (6 months) Consultant, Marketing Strategy @ Created a strategic marketing and implementation plan which included an analysis of market competition, SWOT, as well as relevant economic and financial analysis. Created a competitive marketing strategy for a new “Blue Ocean” technology that involved teaming up with Google and Volkswagen to collaborate on their autonomous vehicle technology.
• Developed marketing and implementation plans
• Provided analysis of automobile market trends
• Provided consumer preference data based off surveys and focus groups
• Created financial analysis of potential profits through joint ventures with different companies
• Created several presentations for the VP of Qualcomm to present to his superiors From August 2011 to December 2011 (5 months) Greater San Diego AreaIT & Logistics Professional @ • Implementation of electronic software systems replacing the old paper-based system
-Evaluated and implemented a 21 CFR 11 compliant electronic inventory system which eliminated the manual (paper-based) tracking of samples and reagents
-Implemented an electronic database system using Microsoft Access for the tracking of daily internal sample use
• Managed the creation and approval of supply requisitions in SAP
• Coordinating internal and external material audits of select agents in accordance with internal procedures and regulatory guidelines
• Provided training to new and existing employees with regard to the use of internal IT systems
• Lead/participated in lean six-sigma projects including:
-Finding lower cost alternatives for laboratory products and supplies
-Process improvements leading to faster laboratory turn around times From 2008 to 2010 (2 years) Document Specialist @ -Provided document management support for Logistics. Duties include retrieval of data from archives, data entry, and data review/verification.
-Performing computer validation testing as per study protocol and verifying calculations and data manipulations including data transposition.
-Additional responsibilities include SOP control and review, general archiving and activity tracking, as well as other activities that support cross-functional quality assurance of DSE. From 2007 to 2008 (1 year) Clinical Research Assistant @ From June 2006 to June 2007 (1 year 1 month)
MS, Business Administration; Focus in Finance @ Pepperdine University, The George L. Graziadio School of Business and Management From 2011 to 2013 BS, Biology, Minor in Management @ University of California, Irvine From 2003 to 2007 Christopher Miyake, MBA, RAC is skilled in: Pharmaceutical Industry, Biotechnology, HPLC, Analytical Chemistry, GMP, Quality Assurance, GLP, Chromatography, FDA, Data Analysis, LIMS, Microbiology, Quality System, Regulatory Affairs, Marketing Strategy
Looking for a different
Christopher Miyake, MBA, RAC?
Get an email address for anyone on LinkedIn with the ContactOut Chrome extension