Ron Weber Email & Phone Number

Radnor, Pennsylvania, United States

Radnor, Pa

- Champion and manage the Quality Department’s general FDA compliance activities including compliance auditing and regulatory assistance for more than 20 medical fill plant sites with revenue >250MM annually.- Provide FDA expertise to ensure compliance with all applicable Federal and State requirements regulating the manufacturing and distribution of drug, device and food products. - Develops and maintains strong partnerships with operations, distribution, and sales leadership in… Show more - Champion and manage the Quality Department’s general FDA compliance activities including compliance auditing and regulatory assistance for more than 20 medical fill plant sites with revenue >250MM annually.- Provide FDA expertise to ensure compliance with all applicable Federal and State requirements regulating the manufacturing and distribution of drug, device and food products. - Develops and maintains strong partnerships with operations, distribution, and sales leadership in assigned region to develop, champion, implement and sustain Quality and FDA Compliance - Actively participates in the development of training materials and trains members of the local Quality Control Unit (QCU) in areas of Current Good Manufacturing Practices (cGMPs)- Performs physical audits annually, and monthly paper audits of drug, device and food manufacturing facilities with the emphasis of analyzing the process to ensure that it conforms to Airgas Medical Drug gas SOPs. - Represent Airgas during on-site inspections by the FDA, other government agencies, and customers. - Maintain expertise regarding current and developing food, drug, and standards and regulations and how they impact Airgas’ business and quality system.- Review and approve validation protocols and final reports.- Conducts follow-up reviews to ensure the completion of CAPA and continued plant compliance to SOPs.- Oversees the investigation of serious medical complaints.- Ensures that any procedural revisions are communicated to the manufacturing facilities and training is conducted.- Assist in providing compliance audit and Annual Product Review feedback to business entity leadership.- Monitor performance against Quality standards and champion continuous improvement. Show less

Newark, De

- Head of the Operations Analytical Global Audit team; includes analytical lab audit of plant facilities globally, a presentation of findings to Plant leadership, followed by a remediation plan with follow-up.- Design, lead, conduct or coordinate as GLP study director or study monitor the overall process for required analytical regulatory studies in order to meet regulatory guidelines.- Function as product and technology analytical focal point for multiple products providing a… Show more - Head of the Operations Analytical Global Audit team; includes analytical lab audit of plant facilities globally, a presentation of findings to Plant leadership, followed by a remediation plan with follow-up.- Design, lead, conduct or coordinate as GLP study director or study monitor the overall process for required analytical regulatory studies in order to meet regulatory guidelines.- Function as product and technology analytical focal point for multiple products providing a single point of analytical contact for other business functions. - Interface with business wide internal customers in order to resolve product issues and transfer technology.- Direct laboratory programs to develop quantitative and qualitative methods, including trace-level analyses and sample preparation protocols for both pipeline and established products.- Apply analytical chemistry solutions to solve customer problems in a timely and cost-effective manner- Train, develop, and supervise contract scientists and interns in a way that enhances their knowledge, skills and capabilities in analytical chemistry and DuPont Core Values. - Know, understand and practice all aspects of DuPont Safety Policies and Principles, including laboratory safety and industrial hygiene protocols.- Manage multiple, concurrent projects/programs and prioritize work to efficiently allocate resources to meet business needs.- Experience with functioning as a member/leader of a larger project team including both internal and external customers/partners/vendors, Strong communication and interpersonal skills.- Experience in leading projects within the workgroup and function (i.e. R&D). Show less

Horsham, Pa

- Responsible for analytical method development, method validation, method transfer and stability analysis for an array of topical skin care products in a GMP environment.- Author appropriate documentation (methods, validation protocols and reports, transfer protocols, etc.) to support generated laboratory data according to SOPs and ICH and GMP guidelines.- Worked in unity with formulation scientists in developing new and innovative products under strict timelines.- Utilized… Show more - Responsible for analytical method development, method validation, method transfer and stability analysis for an array of topical skin care products in a GMP environment.- Author appropriate documentation (methods, validation protocols and reports, transfer protocols, etc.) to support generated laboratory data according to SOPs and ICH and GMP guidelines.- Worked in unity with formulation scientists in developing new and innovative products under strict timelines.- Utilized primarily HPLC (PDA) instrumentation, along with UV-Vis, FTIR, IC, and Karl Fischer.- Proficient using LIMS software to request and locate stability samples and extract product information. - Experienced in analytical software/server upgrade and validation, including the drafting, review and execution of computer/instrumentation test scripts.- Responsible for all raw material testing, analysis, and release prior to use in formulations. Show less

- Adept at Method Development, Method Validation, and Compound Optimization.- Experienced working with triple quadrupole mass spectrometers (API 4000, 5000), both HPLC and UPLC in performing bioanalytical quantitation in a GLP environment. Experienced using and programming automated liquid handlers (i.e. Tomtec, Hamilton, Perkin-Elmer Evolution).- Accustomed to performing analysis, organizing results, then presenting the results. Emphasis placed on meeting all timelines and… Show more - Adept at Method Development, Method Validation, and Compound Optimization.- Experienced working with triple quadrupole mass spectrometers (API 4000, 5000), both HPLC and UPLC in performing bioanalytical quantitation in a GLP environment. Experienced using and programming automated liquid handlers (i.e. Tomtec, Hamilton, Perkin-Elmer Evolution).- Accustomed to performing analysis, organizing results, then presenting the results. Emphasis placed on meeting all timelines and satisfying GLP and SOP requirements. Experience with internal and FDA auditing.- Skilled in Solid-Phase Extraction, Liquid-Liquid Extraction, Protein Precipitation, Derivitization, Immunoassay ELISA, and dissolution and wet chemistry.- Effective at troubleshooting instrument failures and skilled with routine maintenance of instrumentation.- Proficient with Analyst 1.4.2, Empower, MassLynx software, Janiero and Pal Composer (Leap), Lotus Notes, and Microsoft Office applications. Show less

Ms, Inorganic Chemistry

Activities and Societies: American Chemical Society, Villanova Journal Club, Graduate Assistant, Teaching Lab Prep Chemist and tutor

Bs, Chemistry

Activities and Societies: Americal Chemical Society-Student Affiliates, Phi Kappa Theta