Development Specialist II

Location:

Dover, NH

Posted:

September 27, 2024

Contact this candidate

Resume:

Daniel F. DaSilva

207-***-**** **********@*****.***

Summary of Qualifications

Strong leadership, high-energy, strong communication in writing and verbally, cross functional support, producing accurate results under timelines, MS Office, strong documentation bias, strong detail and safety oriented, strong analytical and critical thinker, accuracy of equipment testing, proactive, enthusiastic, initiative, troubleshooting skills, strong organization skills, multitasking, chromatography expert, Skids, AVANT and AKTA explore, column chromatography packing, strong cGMP and GLP knowledge.

Professional Summary

I am a driven professional with over 15 years of experience within the biotech industry focused on Product Process Development and manufacturing productions.

Within the scope of my professional experience, I continuously achieved my ambition to become a successful scientist. One of the methods I utilized to achieve this goal was by exploring existing and innovative techniques over time. As a Process Development Specialist II, I surpassed expectations in all projects I was part of, including but not limited to: lab experiments performance, data results analysis, studies presentations. As Manufacturing Supervisor, I led and supervised the production of mRNA for Covid-19 vaccine. As Manufacturing Associate, 6 months into the role, I was promoted from Associate I to Sr. Lab Associate.

My acquired skills from this industry have made me who I am today; a passionate professional who works relentlessly and tirelessly to surpass benchmarks and contributes consistently to team success.

Opportunity Experiences Relevancy

PROCESS DEVELOPMENT SPECIALIST II SHIRE PHARMACEUTICALS 2008 – 2018

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

·Viral studies team leader

·Developed study proposals and summarized data 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

·Ordered raw material and biological material for lab studies.

·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,

·Promoted from Development Specialist I to II based on performance

Experience

ASSOCIATE SCIENTIST II SANOFI Sep-2022 – Nov-2922

·Downstream studies 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)

·GLP and cGMP trained

·Protein Characterization

MANUFACTURING SUPERVISOR Lonza Mar-2021 to Oct-2021

·Develop weekly goals and supervised team activities at manufacturing production of Modern Vaccine (COVID-19)

·Led team to keep clean room per cGMP regulations.

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

·Overseeing progress of daily schedule to ensure safe and timely completion with quality and excellency for production of mRNA for Modena Vaccine (COVID-19)

·Practice and promote 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.

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

Sr. PROCESS 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.

·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 Jul-2019 to Sep 2020

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

·Kept clean room per cGMP regulations

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

·Trained and certified new staff

·Executed small- and large-scale chromatography of DNA and RNA to support research, development and manufacturing production.

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

·Strong knowledge of quality system CAPA, cGMP and GLP

·Column packing, media preparation, SDS-PAGE Gel

·Operated GE’s AKTA Purifier, PM of Aktas

·Lead Investigations on Lipopolysaccharides (LPS) DNA and RNA on failed batch production.

Bioproduction Training Mar-2019

·Introduction to concepts and principles of biopharmaceuticals and biomanufacturing

·Upstream: setup seed train from cell bank to production. Hands-on experience setting up single-use bioreactor units such as Wave and Xcellerex with understanding of process control strategies

·Downstream: Participated in lab- pilot scale chromatography training,