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.

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.

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).

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.

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.

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