• Engaged and enlisted clients, drafted and negotiated contracts, managed multiple projects simultaneously, managed finances, created marketing materials, plus so much more• Worked with Universities and private laboratories in recruiting investigators, negotiating contracts, and managing projects and staff from design to close-out for BioGuide and clients of BioGuide• Provided consulting services that aided in:o Sourcing laboratories for testing services, designing studies, managing sites, and analyzing & interpreting datao Application of study results to biological systems and disseminating results via publications, white papers, presentations, etc.

Lead a team of QA Specialists in supporting quality functions of design planning, design control, root cause investigations, risk analysis, and Records Reviews/Releases. Providing support for retail and custom products.Responsible for supporting Affidavits, Customer Quality Agreements, Change Notifications, Conditional Releases, Customer Audits, among other customer facing QA responsibilities.An integral part of this role was to foster and maintain good standing relationships with BU partners by manager-to-manager 1:1’s, provide company quality training, and driving/partnering continuous improvements.Products and QMS were governed by ISO 9001, 13485, 14001, 14971, and 21CFR820.Attained certifications for internal auditor of ISO 13485 (CEU 2.4) and ISO 14001 (CEU 1.6). Completed ISO 14971 introductory training (CEU 0.8).Participated in ISO audits, MDSAP audits, and customer onsite audits. Also assisted and led internal audits as part of the internal audit team.

• Point of contact for clients, auditors, inspectors, subcontractors, consultants, and other departments.• Developed and led moderately complex preclinical study designs as needed, served as the primary contact for the client, and kept the client informed of schedule and any unforeseen events or issues.• Studies were under the scope of non-GLP and GLP. Following applicable ISO guidelines and 21CFR58• Established and ensured schedule, budget and quality commitments were met for the client.• Managed internal multidisciplinary team members to ensure that client expectations were met.• Understanding of investigational product(s) including high-level understanding of the Medical Device Development Process.• Evaluated, analyzed, and interpreted study data and presented in a clear, well-organized, scientifically sound report.• Assisted with departmental training as needed.

• Directly supervised three associates and indirectly up-to fifteen technicians. Responsible for hiring, assignment and management of projects, reviews of progress and performance, promotions, and discipline• Designed, executed, and managed an 510k application to the FDA for approval of an IVD assay for Lyme disease• Wrote two first authored manuscripts that were published in peer reviewed professional journals• Designed a web based (Survey Gizmo), post-market survey for one of our long-standing products• Analyzed data for use in regulatory submissions, marketing materials, and professional publications• Wrote and edited policies and SOPs under regulatory standards of CLIA, NYSDOH, and CPDH• Developed and fostered research and business partnerships with national and international partners• Presented research findings to internal and external stake holders, represented company and attended national meetings, trade shows, webinarso Vendor at the AACC Scientific Expo (2015 & 2016) and the ILADS national meeting (2015)o Presented published research findings as a faculty member at the ILADS national meeting (2015)o Facilitated vendor booth at Lumberjack World Championships® 2018 for marketing and selling TicKitTM• Attended and chaired weekly R&D meetings. Also, attended monthly sales meetings as a guest and presenter from time-to-time. • Regulatory committee board member, representing the research and development department

• Performed market analyses: locating suppliers, distributors, and competitive pricing• Provided technical support and maintained product literature by updating company website periodically• Euthanized rats and prepared microtome preparations of brains for testing antibodies• Performed IHC microscopy for online catalogue

Masonic Cancer Center - Pediatrics DepartmentUnder Principal Investigator: Jakub Tolar, M.D. PhD• Researched the childhood genetic disease Mucopolysaccharidosis I (MPSI, Hurler's Syndrome) as well as other childhood genetic diseases. This included working with patient families at times, nurses, patient samples, and maintaining subject data and statistical analysis• Responsible for five mouse colonies, each modeling human genetic diseases. Research involving mouse models included, but were not limited to:o Colonies: cross breading to create NOD/Scid lines, developing genotyping and immune cell phenotyping characterization assays, and following, amending, and drafting IACUC protocols.o drug/cell delivery methods: food compounding, gavage, IP, SC, and eyelid injections, and intranasal applicationso In vivo assessments: fluorescence imaging, MRI, ultrasound, behavior mazes, eye tracking, urine and blood collectiono Post-mortem: harvesting of all organs and tissue samples, CSF collection, microdissection of brains and hearts, cryostat preparations of organs for fluorescence, protein purification• Co-wrote and published five manuscripts and aided in the writing of grant proposals• Supervised five students for three years, including training, assigning tasks, mentoring, and monitoring progress

• Performed statistical analysis to determine efficacy of purification and refolding techniques and enzyme activities • Wrote SOPs and Regulatory documentation• Developed purification and refolding methods for recombinant proteins• Attended weekly R&D meetings, discussed current projects, company financials, and presented educational topics monthly

Worked in a pilot plant performing routine maintenance, product production, and initial laboratory analysisMaintained and analyzed recorded data

Macintosh SpecialistFixed hardware and software problems with Macintosh and Windows systemsPerformed trouble-shooting on computers and networking problemsAttended weekly business meetings

General Chemistry and Organic Chemistry