Cathy Downs Email & Phone Number

Coventry, Ri, Us

North Kingstown, Ri, Us

Laser calibration

Cumberland, Ri, Us

* Works with quality measuring tools to verify product conformity (i.e. micrometers, calipers, optical comparator, microscope, video measuring equipment and CMM ) * Monitors process using quality tools to ensure conformance of products, including following work instructions, prints and other documents.

•LONZA BIOLOGICS, Manufacturing Associate, Hopkinton MA January 2013 – Present (7 months) *Certified to work in a Biosafety Cabinet aseptically sampling and thawing of product.* Working in a cGMP facility manufacturing microbial derived products * Perform basic laboratory tasks (pH, Conductivity, sampling etc…)* Trained & signed off on 100% of CIP/ SIP/ all tank operations/area tasks.* Regular use of Standard Operating Procedures, logbooks and Batch records* Pre-qualified for First level lot review

GENZYME CORP., Manufacturing Associate, Framingham MA 2009 to 2012 * Large scale Upstream manufacturing Cell Culture Lab, tests including the use of sampling with 2-bottle samplers nova septum bags, aseptic techniques and use of laminar flow hood.* Worked with, YSI, BGA, Osmometor and CEDEX in a cGMP environment.* Assisted in start-up GMP biologics facility* Validation and conformance runs, commissioning of equipment* Conducted review of Batch Records and Log books on the manufacturing floor.* Performed operations on Bioreactors, both small and Large.

Basel, Ch

* Attended the First URI training for 3 weeks in a class room, consisting of GMP, the history of GMP, upstream process, downstream process on a small scale, lab work And also what QA and QC are responsible for. * Responsible for Cell Culture Laboratory, lab tasks including monitoring of pH, conductivity, dissolved oxygen, using YSI, BGA in a cGMP environment , developing Cells in Shaker Flasks to 10L glass bioreactor then into a stainless steel Seed bioreactor by consistently feeding them with Media, and ending with Harvest transfer to Purification.* Monitored equipment, performed maintenance and troubleshooting equipment to reduce downtime.* Initiation of work orders and Deviations as needed * Used 5S principles to arrange and maintain the Cell Culture area for improved efficiency

* Responsible for running the equipment for simulations prior to starting up of the new manufacturing line for cell culture. Member of the Clean in Place team using caustic to clean the vessels* Became proficient in running the equipment and validating start up systems* Wrote and revised SOP’s with URS’s and P&IDs.* Simulated start-up using Water for Injection in lieu of media and cells.* Subject Matter Expert on all applicable procedures and train new employees as needed in the modules of the SOP’s to reduce errors and improve productivity and efficiency.* Performed lab tasks including cell counting with a CEDEX machine, sampling pH, conductivity, and BGA to ensure healthy growth, using YSI, Osmometer and BGA in a cGMP environment* Ran complex Millipore system which filtered out the old media and dead cells and replenished with fresh media using a Microfiltration skid which results in cell growth used to extract protein for the Manufacturing Process.

* Assembled, tested, and troubleshoot pneumatic nail guns and manual staplers.* Participated in the Quality circle committee to make jobs more productive and economical for the employee and the organization.* Member of the safety committee team that oversaw the overall plant safety. Made weekly rounds and reported to the safety committee on potential hazards to reduce the possibility of accidents (Including hazardous material and chemical information).

High School Diploma, Business/Commerce, General

Studied Biotech Manufacturing