Jill Williams Email & Phone Number

Menlo Park, California

Responsible for establishing a reagent management framework and compliance for NGS within both CLIA and RUO workflows.

Mountain View, Ca

Led instrument, consumable, and reagent manufacturing operations for high-throughput, nanoscale gene expression & genotyping qPCR systems and NGS library preparation & target enrichment. • Drove the process development, optimization, manufacturing and quality deliverables associated with commercialized product. • Launched new products through creating BOMs, establishing specifications and documenting processes and procedures.• Utilized technical writing and a variety of software programs to analyze/report trends and present project status to project team and upper management. • Assess, qualify and purchase raw materials/lab supplies, qualify vendors/subcontractors, and manage inventory.• Led and managed transfer of technology and reagent manufacturing process from acquisition of NGS Library Preparation product line without increased staffing or lab capacity.• Recognized as Quality Compliance SME by implementing Quality System and associated quality documentation (Wafergen).• Drove team to meet or exceed quarterly revenue expectations as the product portfolio increased by 500% and the staff increased only 50% (Wafergen 2010 – 2016). In 2017, increased staff from 2 to 7 direct reports and took on additional responsibility of instrument and substrate manufacturing management (TakaraBio).• Recognized as SME for knowledge transfer of over 200 Wafergen parts into TakaraBio MRP and Quality System.

Fremont, Ca

Wafergen Biosystems was acquired by TakaraBio USA in March 2017. See TakaraBio USA summary above for details of experience at both Wafergen and TakaraBio USA.

Pleasanton, Ca

PCR Controls, Technical Operations2002 – 2009 Principal Scientist/Manager1998 – 2002 Sr Scientist/Supervisor Responsible for all aspects of the manufacturing of plasmid DNA & RNA stocks within GMP/FDA/ISO guidelines. Utilized PCR technology to perform nucleic acid quantification using both manual and automated sample preparation and amplification/detection methods.• Created a cohesive team of up to 8 direct reports including: hiring, scheduling, budgeting, training, coaching, and performance evaluation.• Conducted preliminary quality review of completed batch records and testing data to verify compliance. Wrote, revised, and executed quality documentation including SOPs, Production Batch Records, Investigation Reports, Corrective/Preventive Actions, and Change Control. Department SME for SAP MRP system, Investigation Reports and Change Control.• Internal auditor and achieved 100% quality compliance within the manufacturing area working directly with regulatory agencies (FDA 21 CFR 820 /ISO 13485:2003).• Assessed new raw materials, established specifications, and coordinated transfer of master cell banks, stocks and test reagents for new products. Provided technical expertise to R&D to ensure smooth and harmonized transition of new products through the Design Control Process into the current validated manufacturing process and test methods. • Led relocation of manufacturing process from Alameda to Pleasanton which increased capacity from 4 labs to 9 labs. Managed dual locations with no increase in staff or budget for 2 years. Authored/executed Master Validation Plan for Environmentally Controlled Facility, equipment validation and process validation of DNA & RNA Positive Control Stocks. • Increased production output by 400% in preparation for transition of department responsibilities from CA to NJ. • Oversaw quality compliance/improvements and provided training/technical expertise for critical manufacturing subcontractor in the Bay Area.

Sunnyvale, Ca

Hercules, Ca

Bs, Biology

Lean Six Sigma Green Belt Certification