Kyle Lopes, PharmD

Experience

• 

  AMC Theatres

  Dec 2006 - Jul 2011

  Staff Member; Supervisor

  • Reconcile shift cash boxes and prepare deposits • Assist with concession sales• Provide the best in-theater entertainment experience resulting in guest approval• Assist management with all floor activities resulting in a perfect working environment• Provide resolution to guest concerns and issues• Uphold and enforce AMC Theater associate rules and regulations• Coach and mentor film and crew members

• 

  CVS Caremark Corporation

  May 2009 - Apr 2017

  Pharmacy Intern

  • Count prescriptions and place in to appropriate containers• Interact with patients by answering or directing any possible questions they may have• Work with insurance companies to revise any problems that occur• Type prescriptions in to the database• Contact patients over the phone to discuss prescriptions and refill requests• Counsel patients and answer questions to the best of my ability• Take quizzes and online courses to stay up-to-date with current policies and information• CVS Pharmacy Database experience Show less

• 

  The Ohio State University College of Pharmacy

  Sept 2009 - May 2010

  Student Assistant

  • Make phone calls to physician offices to verify data resulting in database management• Trouble shoot error documentation• Provide input to resolve issues with applications and data reports• Execute quality tests for auto faxing issues• Data entry in to Centralized Physician Database resulting in financial supervision• Worked with the OSU Medical Center Centralized Physician Database

• 

  The Ohio State University

  Jan 2010 - Jun 2012

  • Teaching about 25 students each quarter in accordance to the Chemistry lecture assigned• Teach students proper laboratory techniques• Teach students proper waste disposal and treatment of harmful materials• Teach and enhance student knowledge of concepts learned in class• Grade papers, lab reports, and Pre-lab assignments• Hold office hours for student questions and problems• Give quizzes pertaining to material learned in class• Proctor exams throughout the quarter • Sort specimens by labeled date resulting in orderly preservation• Add barcode data for permanent entry in Hympenoptera database • Data entry in to excel resulting in permanent safe-keeping of information• Execute necessary tasks associated with maintaining of dry insects • Perform related duties associated with administrative responsibilities

  • Chemistry Lab Teaching Assistant

    Sept 2010 - Jun 2012

  • Data Entry Associate

    Jan 2010 - Aug 2010
• 

  Kroger

  Oct 2010 - Jun 2011

  Pharmacy Technician

  • Count prescriptions and place in to appropriate containers• Interact with patients by answering or directing any possible questions they may have• Work with insurance companies to revise any problems that occur• Type prescriptions in to the database• Contact patients over the phone to discuss prescriptions and refill requests• Counsel patients and answer questions to the best of my ability

• 

  Boehringer Ingelheim

  Aug 2011 - Dec 2015

  •Perform non-commercial qualitative, quantitative developmental chemical and physical test as specified by compendia (USP, JP, BP), regulatory authority (FDA & ICH) for starting materials, packaging components, intermediates and finished products. •Maintain laboratory data in an orderly manner in laboratory notebooks. Performs analytical tasks in compliance with cCMPs, cGLPs, FDA, ICH guidelines to support regulatory submissions, inspections and maintains laboratory cleanliness. •Works independently on assigned projects for filing, responding to deficiency letters and to support experimental batches. Coordinates resources to ensure deliverable timelines and commitments are met •Review and approve test results to ensure consistent national and international quality standards are met •Perform gap analysis and analytical method transfers for Multisource and brand products internally and internationally •Train analysts on new methodology and technology to ensure RFT and compliance•Perform qualitative, quantitative chemical and physical testing and as specified by compendia or specification for API's, starting materials, packaging components and finished products•Maintain laboratory data in an orderly manner in laboratory notebooks, worksheets and documents•Perform peer review of analytical testing documentation•Complete and/or conduct required training according to the laboratory curriculum Show less • Work in new coating area with Coating Pans 4 and 5 and currently being trained on Coating Pan 3• Coat solids from Flow 1 and Flow 2, while maintaining flow throughout the process• Perform operation and changeover of coating equipment and charging equipment• Proactively identify, address and resolve challenges facing my team and department• Collaborate with team members and across the department to improve work processes• Worked with the Performance Center (PC) design group to revamp and improve the PC board for Flow 1• Emergency Coordinator for Coating area on 2nd Shift• Established and maintained systems to measure and monitor relevant performance parameters• Boehringer Ingelheim: PMX, EBR/EQM, E-Forms Show less

  • Scientist I, QC-Quality Control Labs for Finished Product (Flow 1)

    Feb 2014 - Dec 2015

  • Flow 1 Technician

    Aug 2011 - Feb 2014
• 

  West-Ward Pharmaceuticals

  Dec 2015 - Sept 2017

  Managed in-vitro and in-vivo studies to support new and ongoing multi-source products.Responsible for determining regulatory requirements and relaying required information to relevant departments to meet submission requirements.Ensured studies complied with all requirements, such as WIs, SOPs, and GCP’s. Lead critical review of all study related documents.Ensured the appropriateness of the study design based on pharmacokinetic and/or clinical knowledge of the drug product, and all regulatory requirements.Demonstrated leadership skills in the management of studies to independently direct all study related activities to ensure it is conducted to meet time-line requirements.Served as the medical member and worked closely with the Product Development Team (PDT) on all issues surrounding the medical requirements and studies required to demonstrate bioequivalence. Become the medical expert in all pharmacokinetic parameters of the drug substance and knowledgeable about studies to help design future studies.Reviewed relevant information regarding the formulation with Product Development (PD) during the development of the product. Provided input on the formulation and strategy based on the information reviewed.Provided medical review and inputed as needed on additional issues pertaining to product development and post-approval activities for drug products.Responsible for reviewing and ensuring completeness of study data and final reports. Ensured appropriate completion of relevant medical sections of (A)NDAs.Responded to FDA deficiencies and questions as required.Responsible for compiling information and completing all relevant medical sections of INDs for development of products when needed.Responsible for developing and submitting briefing packets with proposed clinical development plans, clinical study protocols, informed consent documents during development of products for FDA review/discussion. Show less • Transfer products (Brand, Multisource, CHC, and ICB) from R&D to Operations, including supporting process development and registration, performing scale-up and validation, start-up of commercial production, and transfer to lifecycle support.• Troubleshoot and resolve obstacles during product development, transfer, validation, and commercialization.• Collaborate with development partners/customers for the process development and registration of new product NDAs and ANDAs, ensuring that all project timelines are met.• Collaborate with development partners (Product development) during development and pilot scale batch production.• Provide critical review of new products/processes regarding fit with operational capabilities (e.g. batch sizes vs. equipment capacity, and technical challenges of the product/process such as poor flow, segregation, or batch splitting, etc.)• Provide feedback to development partners on potential critical mismatches between new products/processes and operational capabilities, and identify potential non-critical process optimization opportunities.• Identify and recommend selection and/or design of processes and systems which meet product and regulatory requirements, and are compatible with our manufacturing practices, while meeting marketing and financial needs. • Create documentation (e.g. SAP Master Data, PMX production procedures, registration batch lot records) based on process design parameters (e.g. formulation and processing steps) from development partners and own critical process review.• Collaborate with development partners to drive shared business ownership, particularly in regards to process performance (Zero Defects, RFT, Throughput Time, Physical Yield, etc.).• Collaborate with Drug Regulatory Affairs (DRA) to support assessment of the regulatory impact of potential process changes, documentation of implemented process changes, and ensure regulatory compliance. Show less

  • Clinical Research Manager in DRA & Clinical Affairs

    May 2017 - Sept 2017

  • Process Engineer II: Production Technology Launch

    Dec 2015 - May 2017
• 

  Abbott

  Sept 2017 - now

  •Responsible for implementing and maintaining the effectiveness of the quality system throughout the entire plant.•Provide Quality Assurance review support to plant projects.•Assure that the plant validation program is executed consistently with the Abbott Validation Policies.•Provide quality support for the introduction of new products and processes to the plant.•Perform Quality Assurance functions for our Calibration Program.•Support process engineering studies, both implementing and initiating, within the Aseptic Department and support on other lines when needed.•Perform GMP and other quality and compliance audits as needed.•Primary support for all external and internal Audits.•Analyze data to develop trends to allow for corrective actions.•Lead and support validation studies and documentation.•Continually developing my knowledge by seeking training opportunities.•Disposition PIRs/QAs/QRs by reviewing all data and making sure that there is no quality impact to the product or process.•Continually update documentation when needed to support the Aseptic line and further developments.•PCQI, HACCP Certified Show less

  • Quality Assurance Manager

    Feb 2023 - now

  • Quality Control Laboratory Manager

    Dec 2021 - Feb 2023

  • Quality Engineer Manager

    Nov 2020 - Dec 2021

  • Sr. Quality Engineer in Aseptics

    Sept 2017 - Nov 2020