This comprehensive case study explores Kymanox’s approach to pharmaceutical manufacturing expansion and technical operations management through multi-site facility buildouts and automation implementation. Our team of Subject Matter Experts (SMEs) collaborated closely with pharmaceutical stakeholders to implement measurable improvements across cleanroom construction, CAPEX program management, automated processing integration, and validation oversight for sterile and injectable drug manufacturing capacity expansion.
CHALLENGE
SOLUTION
RESULTS
- Pharmaceutical company required technical operations support to double manufacturing capacity meeting growth objectives for Private Equity investors.
- Cleanroom buildout, commissioning, and qualification needed for two (2) new ISO 7 cleanrooms supporting sterile and injectable manufacturing operations.
- Expanded storage, automated processing equipment, and continuous improvement support essential for packaging and labeling operations.
- Active Pharmaceutical Ingredient (API) scale-up facilitation, facility shutdown management, and comprehensive process and facility validation oversight required across geographically dispersed sites.
- Led comprehensive Technical Operations and CAPEX program from C-suite strategic planning through on-site change control management and execution.
- Design and managed cleanroom buildouts and facility expansion across two (2) geographically distinct sites in New England and Southern United States.
- Provided technical operations and engineering support for new automated processing machines and expanded controlled substance vault facilities.
- Addressed communication and logistical challenges stemming from different site cultures, geographical separation, and frequent project scope chances.
- Implemented daily project management structure with site-specific touchpoints aligning goals, managing cash-flow constraings, and ensuring stakeholder communication.
- Successfully completed vault expansion, finished good storage, and cleanroom design concept at New England site with refrigeration storage expansion and automation projects tracking positively.
- Achieved 75% completion of cleanroom design at Southern facility with offsite fabrication and electrical service design progressing on schedule.
- Successfully managed complex multi-site CAPEX program without internal engineering team, meeting timelines and budget expectations with positive stakeholder feedback.
- Enabled pharmaceutical manufacturing capacity doubling and project continuity despite site-specific challenges, demonstrating scalable and flexible project management model.