Daniel Lucena Domingues
Process Development Engineer III at Ocular Therapeutix, Inc.- Claim this Profile
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English Native or bilingual proficiency
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Portuguese Native or bilingual proficiency
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Bio
Experience
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Ocular Therapeutix, Inc.
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United States
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Process Development Engineer III
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Oct 2022 - Present
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Graybug Vision, Inc.
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Pharmaceutical Engineer II
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Jul 2022 - Aug 2022
Played a critical role in GMP manufacturing of clinical materials by executing batches, characterizing products, authoring and reviewing quality documents, and training personnel. Achievements: - Produced an Engineering batch of polymer-drug ocular implant using hot-melt extrusion in a cleanroom environment to validate process for GMP manufacturing and support analytical testing. - Managed personnel, maintained batch documentation, and acted as one of the main operators in… Show more Played a critical role in GMP manufacturing of clinical materials by executing batches, characterizing products, authoring and reviewing quality documents, and training personnel. Achievements: - Produced an Engineering batch of polymer-drug ocular implant using hot-melt extrusion in a cleanroom environment to validate process for GMP manufacturing and support analytical testing. - Managed personnel, maintained batch documentation, and acted as one of the main operators in product batches. - Authored and reviewed technical documents to support GMP standards for ocular implant manufacturing. Demonstrated skills: - Adaptability in role changes and ability to take on additional responsibilities. - Attention to details and reliability operating in a GMP environment. - Efficiency in drafting and reviewing documents in aggressive timelines.
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Research Associate I/II
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Aug 2018 - Jun 2022
Worked in the development, manufacturing, and characterization of sustained-release therapeutic formulations for the treatment of ocular diseases, with focus on particle-based polymeric delivery systems and polymeric implants. Achievements: - Developed, characterized, and screened microparticle formulations, which led to the selection of a formulation that advanced GB-102 from Phase I to Phase II clinical trials. - Within a year, validated hot-melt extrusion to manufacture ocular… Show more Worked in the development, manufacturing, and characterization of sustained-release therapeutic formulations for the treatment of ocular diseases, with focus on particle-based polymeric delivery systems and polymeric implants. Achievements: - Developed, characterized, and screened microparticle formulations, which led to the selection of a formulation that advanced GB-102 from Phase I to Phase II clinical trials. - Within a year, validated hot-melt extrusion to manufacture ocular implants, resulting in a scalable, reliable, and GMP-compliant process. - Identified lead GB-401 implant formulation to be used in PK, GLP Tox, and clinical studies. - Established and validated assays to characterize implants, from drug release methods, to assessing mechanical properties such as strength and toughness. - Contributed to the development of a proprietary implant injector by assessing implant loading and injectability, selecting suitable needle, giving operator feedback, and troubleshooting early prototypes. - Trained peers and technicians on scale up processes and analytical techniques. Demonstrated skills: - Experimental design and troubleshooting in R&D and manufacturing environments. - Generate, analyze, and present data in high-level updates. - Equipment, Software, and Techniques: HPLC/UHPLC; Empower and ChemStation; UV-spectrophotometry; in-process sample analysis; drug release analyses; content uniformity analysis; drug loading determination; particle sizing; texture analyzer.
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Johns Hopkins Institute for NanoBioTechnology
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United States
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Research Services
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1 - 100 Employee
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Graduate Student
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May 2017 - Apr 2018
Graduate research in the development of nanoparticle formulations for AMD treatment, comprising complexation and encapsulation of antibodies using flash nanocomplexation (FNC) and flash nanoprecipitation (FNP) methods, and immunotherapy, with the complexation of DNA for improved delivery in vivo. This position has made me proficient in techniques for nanoparticle synthesis and characterization, such as dynamic light scattering and transmission electron microscopy, as well as methods for drug… Show more Graduate research in the development of nanoparticle formulations for AMD treatment, comprising complexation and encapsulation of antibodies using flash nanocomplexation (FNC) and flash nanoprecipitation (FNP) methods, and immunotherapy, with the complexation of DNA for improved delivery in vivo. This position has made me proficient in techniques for nanoparticle synthesis and characterization, such as dynamic light scattering and transmission electron microscopy, as well as methods for drug release assessment. Furthermore, it has improved my critical thinking and troubleshooting capabilities in the laboratory environment. My Master's capstone project on shape-transforming nanoparticles for DNA delivery to tumors was awarded the Johns Hopkins University's Patrick Cummings Prize for Best Independent Research Project of 2018. Show less Graduate research in the development of nanoparticle formulations for AMD treatment, comprising complexation and encapsulation of antibodies using flash nanocomplexation (FNC) and flash nanoprecipitation (FNP) methods, and immunotherapy, with the complexation of DNA for improved delivery in vivo. This position has made me proficient in techniques for nanoparticle synthesis and characterization, such as dynamic light scattering and transmission electron microscopy, as well as methods for drug… Show more Graduate research in the development of nanoparticle formulations for AMD treatment, comprising complexation and encapsulation of antibodies using flash nanocomplexation (FNC) and flash nanoprecipitation (FNP) methods, and immunotherapy, with the complexation of DNA for improved delivery in vivo. This position has made me proficient in techniques for nanoparticle synthesis and characterization, such as dynamic light scattering and transmission electron microscopy, as well as methods for drug release assessment. Furthermore, it has improved my critical thinking and troubleshooting capabilities in the laboratory environment. My Master's capstone project on shape-transforming nanoparticles for DNA delivery to tumors was awarded the Johns Hopkins University's Patrick Cummings Prize for Best Independent Research Project of 2018. Show less
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Treasurer
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Jun 2014 - Mar 2016
Worked as a volunteer and held the position of Treasurer in the Board of Directors of Brazil’s first notional association of biotechnology undergraduate students. Aside from running the treasury, other activities were also performed on demand, such as organizing events; planning courses for raising funds for the association; and administrative/advertising related activities. Major accomplishments include raising and managing financial resources throughout the planning and execution of the first… Show more Worked as a volunteer and held the position of Treasurer in the Board of Directors of Brazil’s first notional association of biotechnology undergraduate students. Aside from running the treasury, other activities were also performed on demand, such as organizing events; planning courses for raising funds for the association; and administrative/advertising related activities. Major accomplishments include raising and managing financial resources throughout the planning and execution of the first national meeting for undergraduate students and graduates in biotechnology, which brought together students from all around the country and went on to become an annual national event. Another relevant accomplishment was being part of the team that wrote a bill, endorsed and submitted for analysis in the federal legislative, aiming to establish guidelines for the exercise of Biotechnology as a profession and bring awareness to it as a field of work in Brazil. Show less Worked as a volunteer and held the position of Treasurer in the Board of Directors of Brazil’s first notional association of biotechnology undergraduate students. Aside from running the treasury, other activities were also performed on demand, such as organizing events; planning courses for raising funds for the association; and administrative/advertising related activities. Major accomplishments include raising and managing financial resources throughout the planning and execution of the first… Show more Worked as a volunteer and held the position of Treasurer in the Board of Directors of Brazil’s first notional association of biotechnology undergraduate students. Aside from running the treasury, other activities were also performed on demand, such as organizing events; planning courses for raising funds for the association; and administrative/advertising related activities. Major accomplishments include raising and managing financial resources throughout the planning and execution of the first national meeting for undergraduate students and graduates in biotechnology, which brought together students from all around the country and went on to become an annual national event. Another relevant accomplishment was being part of the team that wrote a bill, endorsed and submitted for analysis in the federal legislative, aiming to establish guidelines for the exercise of Biotechnology as a profession and bring awareness to it as a field of work in Brazil. Show less
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Undergraduate Researcher
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Mar 2014 - Mar 2016
Laboratory internship position in which I worked in independent and group projects aiming the production of recombinant plant and algae lectins in bacteria under the supervision of professors Benildo Sousa Cavada and Kyria Santiago do Nascimento. Achieved the first reported production and purification of a mature recombinant lectin from Canavalia brasiliensis, a ConA-like, in its soluble and active form in Escherichia coli. Volunteered from March to December 2014 and was a scholarship recipient… Show more Laboratory internship position in which I worked in independent and group projects aiming the production of recombinant plant and algae lectins in bacteria under the supervision of professors Benildo Sousa Cavada and Kyria Santiago do Nascimento. Achieved the first reported production and purification of a mature recombinant lectin from Canavalia brasiliensis, a ConA-like, in its soluble and active form in Escherichia coli. Volunteered from March to December 2014 and was a scholarship recipient from January 2015 to March 2016. Acquired skills include: gene, plasmid and primer designs; heat-shock and electroporation techniques for cell transformation; manipulation of plasmid and genome DNA purification kits; Polymerase Chain Reaction; cell disruption by sonication; agarose and polyacrylimide gel electrophoresis; liquid chromatography methods for protein purification; and protein extraction from plant tissues. Show less Laboratory internship position in which I worked in independent and group projects aiming the production of recombinant plant and algae lectins in bacteria under the supervision of professors Benildo Sousa Cavada and Kyria Santiago do Nascimento. Achieved the first reported production and purification of a mature recombinant lectin from Canavalia brasiliensis, a ConA-like, in its soluble and active form in Escherichia coli. Volunteered from March to December 2014 and was a scholarship recipient… Show more Laboratory internship position in which I worked in independent and group projects aiming the production of recombinant plant and algae lectins in bacteria under the supervision of professors Benildo Sousa Cavada and Kyria Santiago do Nascimento. Achieved the first reported production and purification of a mature recombinant lectin from Canavalia brasiliensis, a ConA-like, in its soluble and active form in Escherichia coli. Volunteered from March to December 2014 and was a scholarship recipient from January 2015 to March 2016. Acquired skills include: gene, plasmid and primer designs; heat-shock and electroporation techniques for cell transformation; manipulation of plasmid and genome DNA purification kits; Polymerase Chain Reaction; cell disruption by sonication; agarose and polyacrylimide gel electrophoresis; liquid chromatography methods for protein purification; and protein extraction from plant tissues. Show less
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Federal University of Ceara
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Brazil
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Higher Education
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700 & Above Employee
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Teaching Assistant
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Feb 2014 - Dec 2014
I was teaching assistant and scholarship recipient in General Biochemistry for the 2014.1 and 2014.2 classes at the Universidade Federal do Ceara. My main responsibilities were to author homework assignments; hold office hours to help students with assignments and general enquiries; lecture when professor was absent; plan and carry out laboratory activities; and mark lab reports and assignments. Additionally, I presented a poster at the Annual Exhibition of Undergraduate Research at… Show more I was teaching assistant and scholarship recipient in General Biochemistry for the 2014.1 and 2014.2 classes at the Universidade Federal do Ceara. My main responsibilities were to author homework assignments; hold office hours to help students with assignments and general enquiries; lecture when professor was absent; plan and carry out laboratory activities; and mark lab reports and assignments. Additionally, I presented a poster at the Annual Exhibition of Undergraduate Research at Universidade Federal do Ceara on a project in which I analyzed student performance in General Biochemistry from 2007 to 2014, in order to assess the impact of changes in academic prerequisites for this class throughout the years. Show less I was teaching assistant and scholarship recipient in General Biochemistry for the 2014.1 and 2014.2 classes at the Universidade Federal do Ceara. My main responsibilities were to author homework assignments; hold office hours to help students with assignments and general enquiries; lecture when professor was absent; plan and carry out laboratory activities; and mark lab reports and assignments. Additionally, I presented a poster at the Annual Exhibition of Undergraduate Research at… Show more I was teaching assistant and scholarship recipient in General Biochemistry for the 2014.1 and 2014.2 classes at the Universidade Federal do Ceara. My main responsibilities were to author homework assignments; hold office hours to help students with assignments and general enquiries; lecture when professor was absent; plan and carry out laboratory activities; and mark lab reports and assignments. Additionally, I presented a poster at the Annual Exhibition of Undergraduate Research at Universidade Federal do Ceara on a project in which I analyzed student performance in General Biochemistry from 2007 to 2014, in order to assess the impact of changes in academic prerequisites for this class throughout the years. Show less
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University of Alberta
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Canada
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Higher Education
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700 & Above Employee
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Summer Undergraduate Research
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May 2013 - Aug 2013
This was a laboratory internship position as part of the Science Without Borders Scientific Mobility Program, for which I was grant recipient. I worked under the supervision of professor Dra. Julia Foght on projects that evaluated microbial degradation of hydrocarbons and analyzed metagenome data, focusing on transposable elements, using bioinformatics. Acquired skills include: prokaryotic cell culture; extraction of secondary metabolites from bacterial cells; analysis of metagenomes using… Show more This was a laboratory internship position as part of the Science Without Borders Scientific Mobility Program, for which I was grant recipient. I worked under the supervision of professor Dra. Julia Foght on projects that evaluated microbial degradation of hydrocarbons and analyzed metagenome data, focusing on transposable elements, using bioinformatics. Acquired skills include: prokaryotic cell culture; extraction of secondary metabolites from bacterial cells; analysis of metagenomes using online and standalone bioinformatics tools; and creating CIRCOS plots. Show less This was a laboratory internship position as part of the Science Without Borders Scientific Mobility Program, for which I was grant recipient. I worked under the supervision of professor Dra. Julia Foght on projects that evaluated microbial degradation of hydrocarbons and analyzed metagenome data, focusing on transposable elements, using bioinformatics. Acquired skills include: prokaryotic cell culture; extraction of secondary metabolites from bacterial cells; analysis of metagenomes using… Show more This was a laboratory internship position as part of the Science Without Borders Scientific Mobility Program, for which I was grant recipient. I worked under the supervision of professor Dra. Julia Foght on projects that evaluated microbial degradation of hydrocarbons and analyzed metagenome data, focusing on transposable elements, using bioinformatics. Acquired skills include: prokaryotic cell culture; extraction of secondary metabolites from bacterial cells; analysis of metagenomes using online and standalone bioinformatics tools; and creating CIRCOS plots. Show less
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Education
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Johns Hopkins University Advanced Academic Programs
Master of Science (M.Sc.), Biotechnology -
Universidade Federal do Ceará
Bachelor's degree, Biotechnology -
University of Alberta
Non-degree mobility program, Biotechnology