• Oversees the technical conduct of the study, including the documentation, analysis, interpretation, and reporting of nonclinical results.• Follows all appropriate regulatory requirements to ensure experimental data are accurately recorded and verified.• Ensures that the protocol, including any changes, are approved and followed.• Ensures that any unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented. • Provides nonclinical expertise and leadership to a cross-functional project team. • Ensures that the study Sponsor is informed on study progress, results, and unforeseen circumstances that could impact study integrity.• Contributes to new proposals by preparing technical sections and providing labor and material estimates.• Supports business development efforts and maintains positive business relationships with external clients. • Authors, updates, and/or reviews standard operating procedures.

Directly manage a team of ~14 individual consisting of Study Directors, Study Research Associates, In life-manager, Quality control personnel and Provantis system administrator. Indirectly manage a team ofIn-life personnel consisting of 15 research technicians and 7 husbandry technicians.• Reported to and worked with the Vice President/site Leader.• Worked with controllers, site lead, and president to create projection model to better understand workload capabilities and month to month revenue projections. • Business development including managing sponsor relationships, project management, protocol development and assisting with budget preparation.• Responsible for all aspects of subordinates’ career growth, including but not limited to, workflow scheduling, coaching, training, development, and deliverance of monthly performance and salary reviews. • Performed periodic review of all applicable SOPS to ensure accuracy and confirm procedures were being perform according to SOPs. Participates in SOP writing, reviews, revisions, and approval.• Maintained sufficient facilities, equipment and personnel are available for evaluation of assigned studies and available as scheduled.• Performed pertinent administrative and supervisory responsibilities relevant to the study management team and staff that support study activity.• Review and improve organizational effectiveness by developing processes, overseeing employees, establishing a highly motivational work environment, and implementing innovative changes.• Delegated responsibilities to the best-qualified employees and enforce all policies, procedures, standards, specifications, guidelines, training programs, and cultural values.• Resolved internal staff conflicts efficiently and to the mutual benefit of all involved.• Participated in in-house training programs for technical staff and ensure appropriate documentation.

Served as Team Lead for the Safety Pharmacology group. Supervisor for junior scientist. Designed and oversaw the planning and conduct of Sponsor driven safety / toxicology (In-vivo) studies, in accordance with FDA, GLP, and MHLW, and other regulatory guidelines. Assisted in maintaining quality of the study by providing scientific and regulatory insight to laboratory personnel and reported study progress to the Sponsor. • Promoted to this level due to my hard work and ability to get projects completed on time with excellent quality in addition to my ability to lead and teach others.• Supervisor of junior scientist• Responsible for all aspects of subordinates’ career growth, including but not limited to, workflow scheduling, training, safety, and deliverance of annual performance and salary reviews. • Function as the single point of control in GLP study. • Team lead and trainer for Safety Pharmacology group• Interpreted and evaluated study data.• Provided scientific expertise and regulatory guidance to sponsors.• Assisted in business development with potential and future sponsors through teleconferences and meetings with a focus on customer service. • Prepared draft study outlines and study proposal for pricing.• Prepared study-specific protocols consistent with the requirements of the sponsor, laboratory SOPs and applicable government and regulatory body guidelines and GLPs.• Communicated study status to the sponsor, including timely communication of unusual study events (i.e., animal death) and generated interim computer data summaries, along with a concise summary of effects.• Prepared and reviewed result section of reports for accuracy, consistency with accepted style requirements.• Responded to audits of methodology and data reports.

Served as the single point of control. Designed and oversaw the planning and conduct of Sponsor driven safety / toxicology (In-vivo) studies, in accordance with FDA, GLP, and MHLW, and other regulatory guidelines. Assisted in maintaining quality of the study by providing scientific and regulatory insight to laboratory personnel and reported study progress to the Sponsor. • Interpreted and evaluated study data.• Provided scientific expertise and regulatory guidance to sponsors.• Assisted in business development with potential and future sponsors through teleconferences and meetings with a focus on customer service. • Prepared draft study outlines and study proposal for pricing.• Prepared study-specific protocols consistent with the requirements of the sponsor, laboratory SOPs and applicable government and regulatory body guidelines and GLPs.• Communicated study status to the sponsor, including timely communication of unusual study events (i.e., animal death) and generated interim computer data summaries, along with a concise summary of effects.• Prepared and reviewed result section of reports for accuracy, consistency with accepted style requirements.• Responded to audits of methodology and data reports.

Severing as the single point of control. Designed and oversaw the planning and conduct of Sponsor driven biocompatibility (In-vivo and in-vitro) studies, in accordance with ISO 10993, FDA, GLP, and MHLW, and other regulatory guidelines. Assisted in maintaining quality of the study by providing scientific and regulatory insight to laboratory personnel and reported study progress to the Sponsor. • Interpreted and evaluated study data.• Provided scientific expertise and regulatory guidance to sponsors.• Overseeing a medical device investigation from start to finish, directly or through regular, detailed communication with other participating personnel.• Assisted in business development with potential and future sponsors through teleconferences and meetings with a focus on customer service. • Prepared study-specific protocols consistent with the requirements of the sponsor, laboratory SOPs and applicable government and regulatory body guidelines and GLPs.• Communicated study status to the sponsor, including timely communication of unusual study events (i.e., animal death).• Prepared and reviewed result section of reports for accuracy, consistency with accepted style requirements.

Responsible for all responsibilities an Associate Scientist including be responsible for management of Assistant Scientists staff.• Promoted to this level due to my hard work and ability to get projects completed on time with great quality in addition to my ability to lead and teach others.• Responsible for all aspects of subordinates’ career growth, including but not limited to, work flow scheduling, training, safety, personnel actions (assist with hiring, terminating personnel, transfers) and deliverance of annual performance and salary reviews. • Manager duties included hiring, termination, performance review, career development, and training of employees.

Responsible for all responsibilities an Sr. Assistant Scientist including training of other personnel and being the lead on special projects. • Promoted to this level due to my hard work and ability to get projects completed on time with great quality.• Worked with clients directly (scientist to scientist) on study related issues• Guided clients on the best course of action when confronted with study related issues • Managed communication with Clients

Responsible for dosing (PO, IT, IV, SC, and Inter cranial using stereotaxic equipment), handling, weighing, necropsy, and sampling of tissue and blood from immune competent and non-immune competent mice. • Assisted with writing of SOP’s and VUF’s.• Managed study-related client communications. • Responsible for provision of timely interim study updates and study reports. • Coordinated and scheduled inter-team studies and projects.• Autonomously performed drug preparation and statistical analysis of study endpoints.

Responsible for helping initiate costing and scheduling requests if needed and draft protocol and amendments for the Study Director review and approval. • Verify for the Study Director that the project schedule sheets accurately reflect the requirements of the protocol. • Trained in the use of specific software and equipment used by Safety Pharmacology (DSI Open Art, Ponemah Analysis system, transmitters, receivers, DEM’s, plethysmography chambers, amplifiers, sigma plot graphing software, etc.).• Responsible for protocol set-up, data selection (ECG cutting and respiratory analysis) data collection and data transfer. • Assist Study Directors in monitoring critical phases of studies and reports any problems or deviations to Study Directors. • Addressed QA audits and client comments relating to reports and ensures that revised or final reports are scheduled and mailed on time. • Responsible for client lab visits, accompanying client during lab visits to observe critical phases and provided data upon request.• Compiled data and drafts summary reports for periodic study progress reports to clients.

Worked closely with Study Directors providing support in preparing of draft outlines and study proposal. Also responsible for preparing reports used for pricing; preparing draft study protocols which were based on FDA and other regulatory guidelines. Served as Principal Investigator for external clients contracting study specific analysis needed for FDA submission and provided assistance to the Study Directors in submission of protocols for review by the IACUC committee.• Communicated with external subcontractors for the Study Director for study specific analysis. • Prepared draft study outlines and study proposal for pricing.• Obtained data from various sources (laboratory, study specific files, automated data capturing system, to assist the Study Director in responding to Sponsor.• Prepared study-specific protocols consistent with the requirements of the sponsor, laboratory SOPs and applicable government and regulatory body guidelines and GLPs.• Assisted in notifying departments of design changes for studies in a timely manner.• Coordinated costing of protocol revisions with pricing department.• Assisted Study Director in communicating study status to the sponsor, including timely communication of study events (i.e., animal death) and generation of interim computer data summaries.

Designed and oversaw the planning and conduct of Sponsor driven non-clinical cardiovascular, respiratory and behavioral studies, in accordance with FDA and other regulatory guidelines. Assisted in maintaining quality of the study by providing scientific and regulatory insight to laboratory personnel and reported study progress to the Sponsor. • Interpreted and evaluated study data.• Provided scientific expertise and regulatory guidance to sponsors.• Assisted in business development with potential and future sponsors through teleconferences and meetings with a focus on customer service. • Prepared draft study outlines and study proposal for pricing.• Prepared study-specific protocols consistent with the requirements of the sponsor, laboratory SOPs and applicable government and regulatory body guidelines and GLPs.• Communicated study status to the sponsor, including timely communication of unusual study events (i.e., animal death) and generated interim computer data summaries, along with a short summary of effects.• Prepared and reviewed result section of reports for accuracy, consistency with accepted style requirements.• Responded to audits of methodology and data reports.

Participated in physiological compound testing with the use of operant conditioning self-administration and drug discrimination models in non-human primates and rodent species. Assisted and maintained research goals and time lines. • Participated in projects investigating the abuse properties of the sponsor’s drug in operant conditioning and functional observation and battery test models.• Demonstrated proficient skills in Med PC software and self-administration and drug discrimination study protocols.• Demonstrated proficient skills in aseptic surgical technique in setting catheters in vascular access ported non-human primates.• Demonstrated proficient skills in good laboratory practices (GLP) protocols.• Achieved Laboratory Animal Technician certification.

Participate in the testing of pharmaceutical compounds with toxicological effects in rodents through various dosing routes. Collected husbandry and dosing data with Provantis Data Collection System. Responsible for the care of small animals on study. Conduct blood collections such as orbital sinus, cardiac puncture and jugular vein.• Achieved Assistant Laboratory Animal Certification. Acquired award for Outstanding Recognition on a Sponsor Study from an Executive Director of Toxicology.• Assisted in compiling research findings for archives in on-going research studies. • Worked with project leader to incorporate training for new research associates into on-going GLP sponsored studies.

Participated in in-vivo behavioral studies such as rat vogel, locomotor activity, radial arm maze, foot misplacement test, accelerated rota rod and object recognition test. Assisted scientist with preparation of drugs and calculation of drugs used for administration.• Researched new information about studies being conducted• Analyzed and graphed data using Sigma Stat and Sigma Plot programs• Participated in Pharma Kinetic and Pharma Dynamic studies (PK/PD)• Blood extraction (cardiac puncture)• Whole brain extraction• Cerebrum spinal fluid extraction (CSF)• Drug dosing of rat and mice, methods included: IP, PO, IM and SC• Blood extraction methods included: cardiac puncture, IV, orbital bleeding and foot puncture• Involved in new drug screening studies