Proven Past Performance
Since 2004, Kymanox has completed over 2000 projects supporting companies of all sizes, from Fortune 500 to startups. We provide engineering, scientific, regulatory, and process operations support services to more than one hundred satisfied, repeat clients in the Biotechnology, Pharmaceutical, Medical Device, and Combination Product industries, all with a perfect safety record.
$60+ Million USD Manufacturing Capacity Expansion Project for High-Volume, Sterile-Filled Medical Device
Provided overall, supervising, and PMP-certified Project Manager to oversee all construction activities, budgets, and CGMP manufacturing readiness. Facilitated key project decision making requiring expert level engineering analyses. Managed facility, equipment, automation and utility commissioning, qualification and validation efforts. Moderated supplier relationships for multi-million dollar equipment and equipment system purchases.
Managed Global Supplier Qualification and Management Program for Large Biopharma Company
In a multi-year program, managed and executed more than 50% of all required supplier qualifications and maintenance audits totaling hundreds of audits across the globe. Scope included suppliers for raw materials, device manufacturing, sterile filling, bulk drug substance production, specialty pharmacy, warehousing, 3rd-party logistics, packaging, and labelling.
Facility Conceptual Design, Construction and Commissioning for $30 Million USD Multi-Purpose, Fill-Finish Facility
Led make-vs-buy analysis and conceptual process design for compounding and filling first-in-class parenterals. Provided owner representation support, overseeing all construction and commissioning activities. Responsible for all master planning, authoring of requirements specifications, and procurement of equipment and key facility systems.
Validation Master Planning, Risk Assessment, Policy and Procedure Development, and Life Cycle CQV for Novel Drug Particle Manufacturer
Developed policies and procedures for initial commissioning, qualification, and validation activities for custom production equipment, lyophilizers, environmental chambers, cleanrooms, computer systems, and clean utilities. Authored Standard Operating Procedures (SOPs), Validation Master Plans (VMPs), test protocols, and final reports. A vast majority of Kymanox’s work was delivered on a fixed-price, fixed-scope basis and done in a competitive procurement process with a 100% win rate.
Implemented Kymanox PMO System at $500 Million USD Global Excipient Manufacturing Company
Developed customized Kymanox policies, procedures, and templates for initial Project Management Office deployment. Trained 30 global employees on the new PMO system and provided two project management resources for initial pilot projects. Defined roles, recruited, and assisted with initial hiring of PMO staff.
Successfully Managed, with Increasing Responsibility, PAI Readiness for Two Orphan Combination Products
Provided Project Management, managed FDA regulatory meetings, qualified entire commercial supply chain, supervised and summarized all process validation and stability programs, and authored CMC section of combination product submission (i.e., BLA). Formulated responses to FDA questions related to bulk drug substance manufacturing and the multi-use autoinjector device.
Addressed New FDA Requirements for Emergency Medical Device Requiring Advanced Reliability Performance
Evaluated FDA enforcement requests for engineering, quality control, and quality assurance improvements. Overhauled risk assessment techniques, sample plans, manufacturing control strategies, analytical test methods, and Quality-by-Design (QbD) approaches to meet all regulatory concerns and improve reliability assurance with additional cost savings related to sampling and sample analysis. Employed novel and advanced statistical techniques to deliver project success and help avert a national drug shortage.
Under Consent Decree Supervision, Validated Entire Asset Portfolio of Automated Drug Product Filling Equipment for a $3 Billion USD Organization
Working with organization's Quality Assurance Unit, supervising FDA Expert Consultancy, and responsible Consent Decree remediation law firm, analyzed production equipment performance and automation controls to provide recommended remediation for full CGMP compliance. Completed engineering studies, commissioning activities, and full validation to restore equipment to CGMP production to avoid imminent drug shortages.