Lab Manager Coordinator

Daniel F. DaSilva

617-***-**** ad5wv8@r.postjobfree.com

Professional Summary

Analytical-driven scientist with over 15 years of experience within the biotech industry focused on downstream processes. Within the scope of my professional experience, I have utilized existing and innovative chromatography techniques and new technologies to optimize drug substances intended to improve lives around the world. My acquired skills from this industry made me who I am today, a passionate professional who works relentlessly and tirelessly to improve life around the world.

Skills

High-energy, leadership oriented, strong communication in writing and verbally, cross-functional, produce accurate results under timelines, strong documentation bias, strong detail and safety oriented, strong analytical and critical thinking, accuracy of equipment testing, MS Office proactive, Innovative, enthusiastic, initiative, organized, multitasking, Skids set up expert, avant and

akta explore expert, column chromatography packing expert, strong cGMP and GLP knowledge.

Experience

ASSOCIATE SCIENTIST II Eteam - SANOFI OCT-2022 – Nov-2923

·Lab Coordinator- overviewing daily activities, kept lab up and running, delegated weekly activities in the lab, trained colleagues on good lab practice (GLP)

·Protein Characterization – Impact, processability and processes stability

·Downstream studies using methods - tangential flow filtration (TFF), UF/DF, IEX, mix mode, HIC, SEC, Affinity (AC)

·Small Scale Column packing proficiency

·GLP and cGMP trained

·Conducted analytical investigations- Find toot cause

·Interpret and analysis data.

·Comprehensive understanding of ISO-13485 and ISO 14971 (Risk Assessment)

MANUFACTURING SUPERVISOR LONZA Mar-2021 to Oct-2022

·Lab Coordinator- overviewing daily activities, kept lab up and running, delegated lab weekly activities, trained colleagues on good lab practice (GLP), managed lab supplies

·Developed weekly goals and supervised team activities at manufacturing productions

·Participated in auditing in auditing to assure excellency, product quality, complacency with cGMP regulations and company’s policies

·Overseeing progress of daily schedule to ensure safe and timely completion with quality and excellency for production of mRNA/ COVID-19 vaccine

·Practice and promoted safe work habits and adhere to safety procedures and guidelines per company policies

·Successfully lead team to accomplish production at manufacturing within timeline and expectations.

·Conducted one on one meetings with operators focusing on work performance and career development

Sr. PROCESS CHROMATOGRAPHY ENGINEER Insight Global -Merck Oct-2020- Feb-2021

·Participate in work group to develop process harvest clarification for chromatography for commercial production of COVID-19 Vaccine.

·Excellent presentation and training skilled

·Kept clean room per cGMP regulations

·Participated in auditing to assure excellency, product quality and complacency with cGMP regulations

·Reviewed SOPs and posted comments for operation team.

·Reviewed spread sheets and created Single use diagram (SUD) for operations.

·Reviewed validation documentation for process Chromatography skids.

·Participated in IQ/OQ/PQ for skids chromatography accuracy.

·Collaborated in writing the skids chromatography methods

·Applied cGMP and GLP knowledge and adhere to safety procedures and guidelines per company policies

SENIOR LABORATORY ASSOCIATE QIAGEN PHARMACEUTICALS Jul2019 to Sep 2020

·Laboratory Coordinator- overviewing daily activities, kept lab up and running, delegated weekly activities in the lab, trained colleagues on good lab practice (GLP)

·Performed small and large scales antibody chromatography to support development and manufacturing production.

·Participated in auditing to assure excellency, product quality and complacency with cGMP regulations and company’s policies

·Team mentor – new technologies

·Chromatography methods utilized (anion exchange chromatography (IEX), mix mode chromatography, hydrophobic interaction chromatography (HIC), and size exclusion chromatography (SEC)

·Strong knowledge of quality system CAPA, cGMP, ISO-9001 and GLP

·Column packing, media preparation, SDS-PAGE Gel

·Lead Investigations on Lipopolysaccharides (LPS) - DNA and RNA

PROCESS DEVELOPMENT SPECIALIST II SHIRE PHARMACEUTICALS JAN 2008–DEC2018

·Executed laboratory purification process unit operations (ultra-filtration, viral inactivation,

·viral filtration, viral studies

· Developed study proposals and analysis data and summarized in written reports and presentations

· Strong knowledge of quality system CAPA, cGMP, GLP, LIMS, TrackWise, ISO-9001

· Team mentor for new employees and lead training on new technology

· Reviewed and corrected SOPs for downstream processing and for media preparation

· Evaluated novel genetic platform technologies that can be applied across multiple programs

·Involved in tech transfer of programs spanning all phases of product lifecycle

· Per DoE, performed experiments in lab/pilot-plant to resolve issues observed during scale-up

·Produced drug substance to support Phase I, II, III studies

·Downstream purification using tangential flow filtration (TFF), UF/DF, (anion exchange

·chromatography (IEX), mix mode chromatography, hydrophobic interaction chromatography

·(HIC), size exclusion chromatography (SEC), Affinity (AC), column packing (BPG, XK)

· Performed antibody immobilization IMP purification,

EDUCATION

·B.S – biological sciences – FAFOPA - training TEACHERS’ university – BRAZIL

LANGUIGE

·English, Portuguese, some Spanish

PHILOSOPHY

·Life is a predocs and all human mind are governed by machination of our brain infrastructure

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