Edwin Buffa Email & Phone Number

Basel, Ch

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

Somerset, Nj, Us

▪ Innovative HPLC Cleaning Method Improvements:o 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:o Demonstrated a commitment to enhancing laboratory efficiency and accuracy, contributing to overall process improvements.

Davie, Florida, Us

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

Largo, Fl, Us

▪ Comprehensive Analytical Testing:o Conducted analysis of finished product, stability samples and raw material (DEA Class 2).o Performed analyte forced degradation studies, eliminating placebo peaks from related compound results in existing “In-House” analytical methods.▪ Instrument Expertise:o HPLC-UHPLC method transfer and troubleshooting to optimize analytical processes.o 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.

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

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

Bachelor Of Science - Bs, Neurobiology And Neurosciences

Bachelor Of Science - Bs, Chemistry