President, co-founder and consultant for PTC Consulting Inc.PTC Consulting Inc. provides consulting services to local and international clients. Our team has a wealth of experience in the areas of product development and manufacturing in the pharmaceutical industry. We leverage this knowledge and experience to support both established and start-up companies who are looking to better understand or optimize their process in order to become more successful. We provide advice that is Practical, Technical and Compliant with a goal of moving your product forward efficiently while helping you meet the quality and regulatory compliance needs of your organization.We provide practical tools with an integrated quality framework that will help you meet your process goals. Utilizing approaches such as Quality by Design (QbD) and risk management, we offer a variety of services that support improved product knowledge and process understanding that will lead to improved success in areas such as process efficiency, technical transfer, scale-up and validation.

Independent consultant applying skills and experience in pharmaceutical industry on a contract basis for project-based work.

Led multifunctional operations team for local site of global pharmaceutical company, including Manufacturing, Shipping and Receiving, Procurement, and IT. Part of Senior Management Team that collaborated with global project teams, overseeing group budget and administration. Accomplishments:- Managed production plan with aggressive timeline, delivering product on time with zero stock-outs or product recalls, for multiple late-stage clinical trials of novel therapeutic cancer vaccine, in collaboration with primary Contract Manufacturing Organization (CMO).- Managed communication for complex and dynamic global production team. Team included internal stakeholders, CMOs, and critical raw-material vendors.- Consistently met group, site, and corporate goals and improved compliance during quality and business audits by empowering and increasing interaction of groups and finding synergies within team to optimize resources.- Implemented on-site and external improvement plans, proactively and as corrective action / preventative action (CAPA).- Directed successful projects in areas of technology transfer, scale-up, process validation, equipment validation and cleaning validation.- Championed improvements and process efficiency projects, within group and site, through interaction and feedback.

Guided Manufacturing team, supplying product to clinical trials and building collaborative relationships with external CMOs and critical vendors. Administered team and group budget. Member of project teams with external licensed partners.Accomplishments:- Scheduled and executed aggressive manufacturing plan, including direct oversight of manufacturing drug product at CMO facility.- Served as subject matter expert (SME) for several technical topics related to manufacture of drug products for human use (visual inspection, cleaning validation, environmental monitoring), ensuring compliance for product safety and quality.- Oversaw, as primary responsible, manufacturing and supporting documentation, ensuring compliance.

Provided pharmaceutical consulting with focus on GMP manufacturing knowledge.Accomplishments:- Performed Quality Assurance (QA) activities, including on-floor coverage of manufacturing activities, batch record review, and validation review for CMO used for API manufacture. Involved in preapproval inspection (PAI) and preparation activities for product that was successfully launched in US market.- Delivered on-floor technical coverage of manufacturing activities for peptide API used in clinical trials. Provided recommendation report to client, focusing on increasing compliance and efficiency during processing.- Reviewed and recommended improvements on manufacturing processes and standard operating procedures (SOP), including controlled area gowning, personnel and material flow patterns, and environmental monitoring programs for multiple clients and CMOs.