Thomas Venetta Email & Phone Number

Durham, Nc, Us

Durham, North Carolina, United States

Raleigh, North Carolina, United States

• Developed, maintained, and worked to continually improve the site training program• Created, revised, and managed the design and development of training program content, instructional tools, hands-on exercises, and computer-based training• Functioned as the site LMS administrator, entering training records and supporting LMS activities for the site as required• Provided information to operations management on recommended training programs, trainee performance, and implementation/maintenance of competency-based on-the-job training (OJT)• Determined, implemented, and maintained training schedules based on departmental workloads and information such as SOP issuance, curricula assignment, and new hires• Conducted the site train-the-trainer program for certification of qualified trainers (QT)• Prepared metrics to ensure compliance with training requirements and participated in audits and inspections serving as the Training SME• Worked closely with site compliance quality assurance (CQA) and manufacturing quality assurance (MQA) employees on various projects, reviews, deviations, CAPAs, and investigations that require training data, records, and training system expertise• Worked closely with HR and site managers in onboarding of all new hires, assigning appropriate training curricula and performing multiple introductory presentations on topics including the site training program, general site quality assurance and compliance, good documentation practices, inspection readiness, cGMP, and 21CFR parts 210, 211, and 11• Experienced in Microsoft Office Suite, Google Docs Editors, Google Classroom, Canvas, Articulate 360, Canva, ComplianceWire, Veeva Vault, and TrackWise.

Oxford, North Carolina

• Instructed 8th graders in science and 9th and 10th grade students in biology and honors biology• Utilized a wide variety of teaching tools and methodologies, including lecture, large and small group discussion, labs, demonstrations, guest speakers, brainstorming, role playing, forums, films, and Powerpoint presentations• Employed Canvas, Google Classroom, and Edmodo online instructional platform to administer course content, assess knowledge, and to connect and collaborate with students, instructors, and parents• Served as head teacher and school representative on an ongoing collaborative community garden project between the school and a local church in Oxford, NC

Henderson, Nc

• Instructed 11th grade first generation college-bound and high need students in honors biology• Served as academic high school and college advisor and mentor for a subset of the 11th grade student population• Utilized a wide variety of teaching tools and methodologies, including lecture, large and small group discussion, labs, demonstrations, guest speakers, brainstorming, role playing, forums, films, and Powerpoint presentations• Employed Edmodo online instructional platforms to administer course content, assess knowledge, and to connect and collaborate with students, instructors, and parents• Served as an Advisory Committee Member for the Vance Granville Community College Bioprocessing Technology Program

• Instructed 7th and 8th grade students in biotechnology and 6th grade students in career exploration• Served as a mentor and cooperating teacher for an agricultural education student intern from NC State• Lead the School Improvement Club• Set up and conducted a job shadowing field trips to GlaxoSmithKline• Applied for and received the Lowe’s Toolbox for Education Grant for school grounds improvements, including an outdoor classroom • Served as a part-time project planner and developed agriculture and agriscience lesson plans for the 2012-2013 Durham Public Schools Encore! Middle School After School Program

• Directed the technical conduct, interpretation, analysis, documentation, and reporting of results of clinical and nonclinical GLP studies in a small, privately-held CRO • Communicated directly with external company sponsors, study monitors, study directors, and principal investigators• Assisted in the generation and negotiation of study budgets • Generated study protocols, protocol amendments, protocol deviations, notes to file, and final study reports • Ensured that studies stayed within budgets and negotiated costs for out-of-scope work requested by sponsors• Followed-up with sponsors regarding outstanding invoices• Provided input to external study directors on patient sample types, volumes, storage, documentation, and shipping• Developed, optimized, and validated analytical methods for the detection and quantitation of drugs, biomarkers, and anti-drug antibodies in support of sponsor clinical trials• Managed projects, activities, and career development of direct reports• Participated in additional company business development activities on an ad hoc basis

• Led a proteomics-based ovarian cancer clinical biomarker discovery program• Directed a subcommittee designed to oversee the development of in vitro diagnostic assay reagents for the screening of ovarian cancer• Directed protein purification method development and technology transfer from an R&D GLP facility to a GMP manufacturing facility• Managed the laboratory scale and pilot lot scale production of diagnostic protein reagents utilized in the development of multiplexed bead-based screening immunoassays for ovarian biomarkers• Developed, optimized, and validated QC test methods (ELISA, SDS-PAGE, IEF, HPLC) for assessment of protein identity, purity, and functional activity • Wrote and reviewed protein production, purification, and quality control test method work instructions and SOPs • Provided technical support and troubleshooting expertise to the cancer staging and serum-based cancer screening assay groups

• Managed six full-time employees, including interviewing, selection, job description preparation, professional development, and performance of yearly job performance appraisals • Managed all group projects and was responsible for all project timelines and deliverables• Acted as technical liaison between Trimeris and its corporate partner, F. Hoffmann-La Roche, for clinical and non-clinical pharmacological studies associated with Fuzeon, the first HIV fusion inhibitor and first injectable HIV medication• Member of the Trimeris-Roche Fusion Inhibitor Core Clinical, Clinical, and Non-Clinical Teams• Identified contract research organizations, designed study protocols, generated Requests for Proposals (RFPs), negotiated cost structures, monitored outsourced nonclinical ADMET studies, visited study sites, and conducted studies according to regulatory requirements • Performed all nonclinical and clinical pharmacokinetic and toxicokientic data transformations, and compiled data for various sections of numerous regulatory document submissions to the FDA • Worked with legal to prepare Mutual Disclosure (confidentiality) and Materials Transfer Agreements (MTAs) for use in collaboration with outside vendors

Durham, North Carolina, United States

• Managed two full-time employees, including interviewing, selection, job description preparation, professional development, and performance of yearly job performance appraisals • Developed proprietary ELISA and HPLC bioanalytical methods and oversaw the technology transfer of those methods to contract testing facilities • Assisted in the generation and compilation of data for regulatory submissions to the FDA • Performed nonclinical and clinical toxicokinetic, pharmacokinetic, and specific immune function assessments• Assisted in the non-clinical and clinical evaluation of an insulin pump drug delivery device (MiniMed) for use in the subcutaneous delivery of Fuzeon• Assisted in the preparation of an NIH Phase I grant proposal and was named a Co-Investigator

Durham, North Carolina, United States

• Managed two full-time employees, including interviewing, selection, job description preparation, professional development, and performance of yearly job performance appraisals • Assisted in the generation and compilation of data for the IND application for Fuzeon, a novel inhibitor of the Human Immunodeficiency Virus • Developed, optimized, and validated bioanalytical methods in support of drug development activities • Assisted in the writing of two SBIR Phase I grant applications and was named a Co-Investigator on both

Durham, North Carolina, United States

• Initiated and monitored all preclinical studies associated with the drug development program for Fuzeon, a novel inhibitor of the Human Immunodeficiency Virus • Developed, optimized, and validated bioanalytical methods and high through-put microplate-based drug discovery screening assays

Morrisville, North Carolina, United States

• Developed reagents for proprietary immunoassays for a number of clinically relevant cardiovascular biomarkers

Durham, North Carolina, United States

• Performed protein chemistry and monoclonal antibody characterization in the development of rapid medical diagnostic immunoassays

Durham, North Carolina, United States

• Participated in all aspects of diagnostic immunoassay development, from generation of monoclonal and polyclonal antibodies to their use in ELISA and RIA • Cultured cells in roller bottles and hollow-fiber bioreactors for internal use as well as for external customers• Obtained master’s degree while working full-time

M.S., Biotechnology

Certification In Agricultural Education

B.S., Biology

Education record