Ron Mcmaster Email & Phone Number

Easton, Pa, Us

Boston, Massachusetts, United States

Responsible for technical oversight at CMOs for process development, technical transfer, clinical manufacturing, validation activities through PPQ / commercialization of sterile, parenteral vaccines.

Swiftwater, Pennsylvania, United States

Provide leadership for three manufacturing facilities generating > $600M in annual revenueLead a team of > 100 people (7 direct reports)Accountable for meeting safety, quality, delivery and cost metrics for all areas of responsibilitiesLead inspections for US FDA and International health authorities, including facility tours, process descriptions, annual product reviews, continual process validation, and all compliance related questions / issuesResponsible for recruitment and development of a motivated staff, including succession planning ensuring continuity of leadership when personnel changes occur.

Swiftwater, Pennsylvania

Roles since 2008:1. MTech Lead for new facility construction, validation, licensure and launch (2008 – 2012)2. Head of the Bacterial Platform (2012 – 2015), Managed 30+ employees3. Conjugate vaccine SPP (2015 – 2018)Notable successes include:1. Oversight of the process development, equipment design and process validation of a new bacterial polysaccharide manufacturing facility, licensed in 2010.2. Transfer of a polysaccharide:protein conjugation process to a new facility with improved compliance and optimized process, licensed in 2015 (FDA) and international markets3. Led the transfer and scale-up of monoclonal antibody production to support clinical studies.Responsibilities as a product/process specialist include:1. Interactions with Health authorities during routine inspections and technical discussions.2. Lead investigations of critical deviations, OOS and OOT results, determine product impact and risk to supply3. Lead studies to improve process robustness, compliance, and yield.

Swiftwater, Pennsylvania, United States

Managed a team of fermentation, purification, conjugation and analytical scientists.Led the execution of process development, scale-up and validation of new manufacturing processes; and improves the robustness, yield and compliance of current manufacturing processes.Present and discuss submissions and issues with Health Authorities (FDA and International) during compliance inspections, prior approval inspections and commitments for approvals, technical meetings as well as the preparation of annual product reviews.Notable successes included1. Development, validation, scale-up, CMC submission preparation, licensure and launch of a new vaccine licensed in 2005.2. Supported the modernization and licensure of a legacy bacterial toxoid vaccine, licensed 20063. Successful 3-fold scale-up and licensure of an existing conjugate vaccine, licensed 2007

Swiftwater, Pennsylvania, United States

Direct process development activities for the purification of sterile protein, polysaccharide, and conjugate vaccines prior to scale-up and transfer to Manufacturing facilities.Manage scientists and technicians to perform small-scale optimization, process improvement, process demonstration, and analytical development/validation.Lead scale-up activities for transfer into cGMP manufacturing facilities, including production of phase 1, 2 and 3 batches.Lead multiple cross-functional project teams for development, validation and licensing new products and improving manufacturing process yields and purity.Led crisis team to restore license suspension of a polysaccharide vaccine after a market withdraw

Swiftwater, Pennsylvania, United States

Coordinate the process development activities for vaccine candidates (native and recombinant proteins, bacterial polysaccharides and polysaccharide:protein conjugates).Responsible for documentation and cGMP manufacturing of products for use in phase I/II clinical trials.Coordinate the transfer and scale-up to manufacturing of protein purification and conjugation processes.Equipment, cleaning, and process validation protocols/reports.Prepare IND CMC sections.Develop and validate PAT methods to monitor product quantity and quality.

Swiftwater, Pennsylvania, United States

Developed and optimized polysaccharide:protein conjugation and protein purification processes.Responsible for all necessary documentation used for the preparation of materials to be used in phase I/II clinical trials.Submitted technical reports to update management on project status.Document preparation (batch records and operating procedures).

Biochemistry And Molecular Biology

Master Of Business Administration (M.B.A.), Technology Management

Ms

Bs