Lea De Rosa Email & Phone Number

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania

Greater Philadelphia Area

• Effectively manages and leads a team of four to six technicians by delegating daily tasks to ensure successful assay completion of customer supplied samples
• Conducts, directs, and trains technicians in lab procedures, assays, gowning for BSL2+, and aseptic techniques according to and in compliance with GLP, cGMP, CFR, and SOPs
• Proficient in cell counting, seeding, inoculation, feeding, passaging, harvesting, and cytotoxicity observations (C8166-45, HEK, MRC-5, VERO, CHO)
• Works safely with HIV, adeno virus (hAd-5) and adeno-associated virus (wtAAV2) vectors utilizing ELISA and qPCR as endpoint assays
• Maintains lab organization and stock levels weekly through ordering, tracking, and restocking supplies by proactively scheduling and preparing lab work and materials

Wayne, PA

• Proficient in Creo Parametric for modification and development of instruments for spinal fusion
• Trained in ASME Y14.5 geometric dimensioning and tolerancing
• Experienced in writing DMRs and DHFs for implants and instruments used for spinal fusion
• Thorough understanding of developing and implementing implant inspection drawings
• Knowledgeable in spine mechanics and intervertebral fusion devices

Quaktertown, PA

• Utilized GMP, QSR, and ISO standards to design and develop a variety of implantable textile medical components
• Developed and implemented internal specifications for textile production
• Developed, documented, and oversaw Process Qualifications for equipment
• Performed component finishing and QC analysis on textile medical components
• Used RCA boards, deviation reviews, and CAPAs to implement quality changes based on customer and internal feedback
• ISO13485 Internal Audit trained through Oriel Stat A Matrix

Conshohocken, Pennsylvania

• T
• Trained in cGMP documentation, gowning, and aseptic technique
• Utilized Trackwise, MERPS, CDISY, and IP21 to track and validate processing
• Experienced in large-scale centrifugation and filtration recovery processes for proteins
• Proficient in large scale HPLC separation including blue affinity, DEAE, CMSFF, QXL
• Experienced in UF/DF procedures including sterile final fill operations

Philadelphia, PA

• Limited T-cell infection rate of transfected pseudo-HIV to 5.18±5.5 in vitro due to conjugated nanoparticle “popping” HIV powerhouse cells determined by antibody and inhibition assays
• Developed an osmotic pump based delivery system encapsulated in a film of microhooks and microneedles for controlled, long term release of the peptide conjugated to gold nanoparticles
• Began optimization of production method of shape memory polymer for large scale production using hazardous chemicals including NMR analysis
• Performed ASTM F813-07 on seeded HOS cells to determine overall cell viability in vitro
• Performed a set of tests from ISO 10993 series to test biocompatibility of polymer along with local effects post implantation of the device

Exton, PA

• Machined Orteq Actifit medial and lateral meniscus scaffold
• Completed Orteq Actifit dimensional verification, suture pull mechanical testing, and metal detection
• Completed Emerge Medical cortex and cancellous bone screw and driveshaft pin first article inspection (FAI), dimensional verification, sandblasting, cleaning, and visual standards (QC) inspections
• Developed test method for inspecting drill pin tips for debris and trained supervisor

Malvern, PA

• Utilized E. coli for cloning as a plasmid vector for small scale protein growth and production
• Small and large scale protein expression using TSB and LB broth: Ubiquitin, SUMOmet3 GFP, Ub/SUMO mesna, NEDD8intein
• Used small scale HPLC purification and LCMS analysis to develop final concentrated protein product
• Produced new nickel chromatography columns after extended periods of use for protein purification
• Managed an extensively detailed lab notebook to document efforts for company reference

Reading, Pennsylvania Area

• Developed published protocols and final reports regarding mechanical and material laboratory tests of CHDCs (Chronic Hemodialysis Catheters)
• Performed daily tensile, leakage, and structural property testing on CHDCs
• Performed accelerated aging ASTM F1980 and distribution simulation testing ASTM D4169
• Managed hazardous chemicals in materials laboratory and documented confidential data

Master Of Science (Ms), Biomedicine And Business

Biomedical Engineering, Biomaterials And Tissue Engineering

Activities and Societies: National Leadership SocietyStudied Biomedical Engineering concentrating in Biomaterials and Tissue Engineering.