About

Lab Safety

• Hazardous material risk assessment and handling:
• Implementation of a risk assessment process and tiered engineering controls to ensure proper handling of any material through any process.
• Industrial Hygiene: Anticipate, Recognize, Evaluate, and Control hazards, including chemical, biological, physical, ergonomic, and air.
• Develop and implement Biological Safety Program to ensure safe operations and handling for BSL2+ materials and bloodborne pathogens.
• Develop and implement chemical hygiene plan.

Microbiology

• Led a microbiology team to successfully validate and analyze complex or otherwise challenging sample matrices that multiple competing technical teams could not, across non-sterile enumeration and pathogen culture techniques, kinetic and gel-clot based endotoxin testing, and sterility.
• Understand and Implement Rapid Testing Technologies to accelerate turnaround times and improve outcomes with analytical signals.
• Identified and mitigated a decade-long misunderstanding in endotoxin analysis resulting in no adverse customer outcomes.
• Identified and built a solution for compendial revisions to highly complex antibiotic assay techniques and methodologies to ensure compliance and accuracy.
• Built and executed validation and routine monitoring plans for multiple customer facilities, inclusive of process gas, room air, and water system sampling for purity, microbial and chemical, and particulate quality.

Lab operations

• Converted a manual and cumbersome project and revenue tracking process to a streamlined and highly efficient system, reducing hands-on management time and increasing accuracy significantly.
• Optimized Laboratory Layouts for improved efficiency using 5S methodologies
• Led the search and planning of new laboratory locations, including comprehensive build-out plans, long-term utility and technical requirements, geographical optimization for employee commute and customer proximity, and associated moving, validation, equipment, building, and overhead costs.
• Optimized quality systems to improve turnaround times in quality review, including documentation harmonization and process optimization.
• Leadership building: Enabled and facilitated training and mentorship of site leadership to operate autonomously.
• Implemented rigorous cost and price evaluation process for over 3,000 service items, leading to best-in-class profitability and strategic thinking around these metrics.
• Successfully developed and implemented electronic systems for lab operations tracking, Salesforce lead-to-quote, LIMS, ELN, and Central Monitoring Platforms (temperature, humidity, etc).

Project highlights

• Built the business case and diligence to transfer site ownership in a multi-million dollar transaction.
• Brought a $3.5M investment in sterility testing services from conception through business case review and approval, build-out, and launch.
• $1M laboratory relocation with strategic service expansion, 50% YoY growth.
• Completed laboratory turnaround encompassing culture shift, leadership development and mentoring, and FTE expansion to support key customer programs.
• Built a microbiology laboratory from the ground up, inclusive of equipment and laboratory build-out, SOP authoring, team selection and training, customer acquisition.
• Transferred highly regulated work and contracts between facilities.
• Comprehensive LIMS and ELN selection process for 20+ laboratories across R&D and Manufacturing/QC global network, through development, validation, and launch.