Manager Safety

LUCY DIRNU

**** ******* **. ****** ******, CA ***46, *********@*****.***, 510-***-****

https://www.linkedin.com/in/lucy-dirnu-08b18611

Scientist Senior Research Associate C hemist TECHNICAL SUMMARY

Scientist/Chemist Qualified by: 8+ years of expertise in development settings for synthesis and purification of oligonucleotides according to ISO 13485 guidelines, used in PCR and DNA sequencing applications, DNA q uantitation, data analysis and problem solving. Skilled in process improvement, safety, and waste management.

Senior Research Associate Qualified by: 6+ years R&D M edical devices, laboratory managerial, GMP/GLP/GDP, FDA, new product development, material properties, formulation, bench scale to pilot scale, design of experiments, analytical characterization, SOP’s, p rocess improvement, problem solving, stability studies, metrology measurements, clean room environment, batch records, manufacturing tech transfer, presentation. Research Associate Qualified by: 5+ years R&D M edical devices, laboratory managerial, surface modification and characterization of soft materials, polymer synthesis/characterization, contact lens solutions improvement, teamwork, safety coordinator, effective communication. Instrumentation & Technologies: 3 900/AKTA, MarMades DNA/RNA synthesizers, B eckman, UV/ Vis Spectrometer, HPLCs( Ion Exchange and Reverse Phase), LC-MS, ESI, Karl Fisher analysis, calorimetry, IR, oxygen permeability (Dk), water content (EWC), modulus measurements

(Instron), contact angle (CA), FTIR, viscometer, plasma treatment, particle size analysis.

PROFESSIONAL EXPERIENCE

Thermo Fisher Scientific, P leasanton, CA Oct 2017- Present Scientist

● Develop processes for the manufacturing of oligonucleotide products using a variety of synthesizers, cleavage and deprotection, HPLC purification, MS, Spectrophotometer, liquid handlers, etc.

● Work with team to investigate trends, conduct root cause analysis, implement corrective action for processes and collaborate with departments across the organization such as suppliers,operations, logistics,QA,EHS to resolve technical issues and support products.

● Present research findings and analysis in meetings, wrote technical reports and BOMs.

● Assist in the verification process and transfer of the new products in manufacturing labs. Coopervision, R&D, Pleasanton, CA Oct. 2 005 - Dec.2016 Senior Research Associate, 2008 - 2016

Research Associate, 2005 - 2008

● D eveloped novel copolymers for contact lens including synthesis of in house polymer, incorporation of new raw materials, toxicological assessment, formulation “screening,” optical lens design, molding, casting, curing, demolding, extraction of residuals, final hydration, packaging and sterilization.

● E xpert in material analysis techniques on incoming raw materials, in-process samples, finished products and stability samples.

● E valuated results, identified the root cause of undesired property, polymer synthesis or raw materials and drew conclusions leading to product improvement and finalization.

● E xperienced working on multiple projects from bench scale to pilot to manufacturing sites.

● T rained other team members in lens formulations and fabrication techniques and safety procedure.

● L ed group projects and presented research findings and analysis in meetings and forums.

● Managed lab safety tasks in order to reduce recordable accidents and coordinated all lab equipment setup and calibration with external vendors.

● S erved as a member of safety committee to audit labs and to direct lab manager to correct identified problems.

● E xemplified leadership by coaching and inspiring fellow employees to reach company-sponsored wellness goals, resulting in recognition as one of Bay Area’s Healthiest Employers. Thermo Fisher Scientific, P leasanton, CA May 1997- June 2005 Scientist, 2000 - 2005

Chemist, 1997 - 2000

● D eveloped and manufactured Kit Oligonucleotides following SOPs in compliance with GMP, followed by HPLCs (Ion Exchange and Reverse Phase) purification, quantitation, characterization and UV/Vis Spectrometer ensuring production activity and in process quality control.

● P erformed a ssays on nucleic acids, arithmetic calculation to determine the desired concentration in the formulation process.

● I mproved manufacturing processes and shortened production lead-time by checking ongoing production runs to identify and solve instruments problems, t roubleshooting and m aintenance.

● R eviewed and edited SOPs regularly to ensure relevancy with work practice.

● C oordinated the implementation of a 5S Process Excellence Program.

● C oordinated the safety program updating personnel on safety issues and training, and took measurements to reduce recordable accidents.

Clorox R&D, W alnut Creek, CA A pril 1996 to June 1997 Research Associate

● R esearched resources to implement improvements to the quality of Patent Pending 1996 Armor All Products Corporation by comparison to other products on the market.

● A nalyzed various Armor All products to evaluate their chemical characteristics. EDUCATION

Polytechnic Institute of Bucharest, Bucharest, Romania Bachelor of Science, C hemical Engineer and Polymer Technology San Jose State University, S an Jose, CA

Pursued Master in Science, Organic Chemistry and Polymers

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