Edwin Buffa

Lonza                                                                                                                                                      04/2019 – 12/2021

Research and Development Pharmaceutical Chemist                                                                                            Tampa, FL

• Analytical Method Development and Validation:
  • Led development and evaluation of analytical methods for new chemical entities (primarily anti-neoplastics) across multiple clinical trial stages.
  • Demonstrated expertise in drafting and preparing comprehensive analytical reports for clients, effectively communicating results and insights.
  • Successfully validated and optimized assay, related substances, and dissolution methods; ensuring compliance with regulatory standards.
  • Conducted dissolution profile comparison (f1/f2) studies to assess formulation consistency, contributing towards regulatory compliance.
• Solubility Studies and Media Optimization:
  • Performed equilibrium solubility studies in order to establish optimum media for sink conditions.
  • Contributed to improved product performance by optimizing dissolution media for different drug formulations, enhancing efficiency in analytical testing
• Regulatory Compliance and Quality Assurance:
  • Demonstrated commitment to quality by adhering to company Standard Operating Procedures (SOPs) and through attentive peer review of data.

Catalent Pharmaceuticals                                                                                                       03/2020 – 09/2020

Research and Development Scientist                                                                                                                  Saint Petersburg, FL

• Innovative HPLC Cleaning Method Improvements:
  • Modified, optimized and validated “In-House” analytical methods to achieve accurate and reliable cleaning analysis of formulation equipment, enhancing both laboratory and manufacturing process efficiency.  On average, reduced company cleaning method verification injection time by 70%.
• Quality and Efficiency Advocate:
  • Demonstrated a commitment to enhancing laboratory efficiency and accuracy, contributing to overall process improvements.

Green Scientific Laboratories                                                                                                 01/2019 – 04/2019

Lead Scientist                                                                                                                                                  Davie, FL

• Quality Systems and ISO/IEC 17025 Accreditation:
  • Successfully prepared for and achieved ISO/IEC 17025 accreditation by implementing a robust quality system in a newly opened cannabis laboratory.
• Analytical Expertise:
  • Developed and validated a HPLC/UV method for the determination of over two dozen cannabinoids in extremely diverse and complex sample matrices.
  • Utilizing GC/MS and LC/MS instruments, quantified terpenoid and pesticide content in bulk hemp/cannabis product, ensuring compliance with regulatory standards.

VistaPharm, Inc.                                                                                                                         01/2014 – 11/2018

Chemist III                                                                                                                                                     Largo, FL 

• Comprehensive Analytical Testing:
  • Conducted analysis of finished product, stability samples and raw material (DEA Class 2).
  • Performed analyte forced degradation studies, eliminating placebo peaks from related compound results in existing “In-House” analytical methods.
• Instrument Expertise:
  • HPLC-UHPLC method transfer and troubleshooting to optimize analytical processes.
  • Developed a novel method to utilize “Windows User Rights Permissions” to create and implement a strategy to maintain data integrity and 21 CFR Part 11 compliance with regards to Perkin Elmer’s TotalChrom CDS.

Belcher Pharmaceuticals                                                                                                          01/2013 – 12/2013

Project Manager (Sterile)                                                                                                                                   Largo, FL

• Project Management and Pipeline Development:
  • Identified and communicated new pipeline projects, strategically defining reasonable and achievable timelines to align with company goals.
  • Led facility design and development of an ISO Class 5 laboratory; crucial for sterile ophthalmic and inhalation product development.
  • Procured active pharmaceutical ingredient (API) and analytical instrumentation to support research and development initiatives.
• Confidentiality and NDA Management:
  • Executed non-disclosure agreements (NDAs) to protect sensitive information and maintain confidentiality in research and development endeavors.

Nephron Pharmaceuticals                                                                                                        10/2011 – 11/2012

Associate Scientist                                                                                                                                         Orlando, FL

• Formulation Development and Project Leadership:
  • Developed a novel technique for accelerated stability analysis and simulated shelf-life determination of inhalation suspension formulations utilizing induced gravitational stress by centrifugation.
  • Played a key role in reverse engineering innovator inhalation and ophthalmic drug products, contributing towards aNDA submissions to the FDA.
  • Led high-impact projects, including the development of preservative-free nebulized solutions and suspensions.

University of Miami                                                                                                                                   05/2009 

Bachelor of Science, Neuroscience (Neurobiology)                                                                                         Coral Gables, FL

Minor Chemistry