Oscar Gonzalez, M.S., Mba, Lssbb Email & Phone Number

As CEO and President of Sigma Lab Consulting, I lead our mission to drive operational excellence in the life sciences, collaborating closely with clients to optimize their processes and enhance interdisciplinary communications. In addition to overseeing our strategic direction, I work directly with clients across R&D, clinical, and manufacturing.

Cambridge, MA, US

Leading the creation and implementation of a project management structure focused on coordinating projects across the entire Research and Development organization. Including but not limited to project timelines, action items and minutes, and development of project level dashboards with automations.-Initiated project management development trainings for the.

Newton, MA, US

• Daily oversight of Selinexor program clinical trials (1 Ph3, 2 Ph2/3) to monitor progress and ensure milestone achievement.
• Management and mentoring of program planning and analytics team members.
• Defined processes and procedures related to reporting and dashboards for executives.
• Created and implemented program-wide structure for management, communication, and cross-functional collaboration of projects with internal and external stakeholders.
• Coordinate timeline and prioritization to stakeholders.
• Support planning and allocation of resources and expertise to meet project objectives and escalate issues as appropriate including bottlenecks, timeline impacts, and knowledge gaps.

Newton, MA, US

• Track and support the development of detailed, product centric, project plans including strategy, timeline and budget for drug discovery and development programs
• Analyze and track the execution of product development activities against agreed project plans including coordination and control of resources and identification and mitigation of risks
• Coordinate across internal and external functional groups to achieve plan objectives and meet timelines, including discovery research, preclinical evaluation, regulatory affairs, medical writing, manufacturing.
• Support planning the correct allocation of resources and expertise to meet project objectives and escalates issues as appropriate including resource bottlenecks, budget variances, timeline impacts and knowledge gaps
• Collaborate cross-functionally to secure funding (internal or external) to achieve program objectives
• Support the Chief Development Operation Officer (CDOO) in all aspects related to executive oversight and management of the program and pipeline portfolio.

Newton, MA, US

• Prepare nonclinical report amendments for New Drug Application (NDA) submission to the FDA.
• Serve as Chemical and Biological Safety Officer
• Maintain logs and storage of Karyopharm Sponsored Clinical Trial Samples andInvestigator Sponsored Clinical Trial Samples
• Reconcile discrepancies on samples received, with the clinical site and Clinical Trial/Clinical Project Manager
• Manage laboratory purchases including chemicals, biologicals, consumables, andequipment purchases
• Coordinate, supervise, and train high school summer interns

Boston, MA, US

- Ensure adherence to Environmental Health and Safety guidelines mandated by Boston University for the HIV quadrant (3 Labs).- Manage chemical acquisition management and waste disposal for HIV quadrant.- Liaison for Biological, Chemical, and Fire Safety Inspections performed by the Environmental Health and Safety Officer.- Attend medical school wide.

Boston, MA, US

- Research focuses on assay development, optimization, and implementation regarding neutralizing antibodies and HIV co-receptor usage.- Responsibilities include isolation of Peripheral Blood Mononuclear Cells from whole blood, expansion of various HIV stocks, cell culture maintenance, and ordering and maintenance of lab equipment and supplies.- Chemical.

Boston, Massachusetts, US

• Assist course instructor in setting up laboratory exercises.
• Plan, write, and distribute additional practice handouts and general lab etiquette handouts.
• Hold study sessions for students seeking extra one-on-one instruction on cell culture techniques and mathematical computations.

Boston, MA, US

• Observed clinical dictation of patient cases by residents and attending physicians.
• Observed implementation of protocols for PET, SPECT, and CT imaging including patient care, radioisotope handling and use, and modality specific programs.
• Became familiar with common radioisotopes used in the clinic for specific diagnostic procedures.

Norfolk, Virginia, US

• Research explored the pathways involved in how a proteolytic deficient SIAH2 abolishes different cancer lines.
• Developed protocol for immunofluorescence of a 3Dl culture and generated stable inducible cancer lines for in vivo experimentation
• Responsible for controlling inventory and ordering of lab supplies, reagents, and chemicals
• Maintained over 5000 genetically mutated Drosophila melanogaster cultures
• Trained graduate students on research techniques, communicated with senior personnel at EVMS, and ensured biological and chemical safety compliance of lab.

Winston-Salem, NC, US

• Explored the role of EphA2/ephrinA1, receptor/ligand complex, in the migration, invasion, and invadopodia formation of Glioblastoma multiforme (GBM)
• Performed cell culture, transfection, PCR, immunofluorescence, gelatin zymography, and western blot to create GBM cell lines with naturally expressing genes.

Winston-Salem, NC, US

• Performed cell isolation, culture, and characterization of human skeletal muscle for the optimization of human muscle progenitor cell culture for autologous implantation of muscle injury patients.
• Responsible for H&E staining as well as immunohistochemistry for cultured human and porcine skin samples
• Completed for evidence of proliferative cells within a physically stretched skin sample for implantation of burn victims.

• Researched the effects of small intestinal submucosal scaffolds on a rat following a simulated birth injury by vaginal distension.
• Assisted a graduate student in his thesis work testing for the stress/strain, tension strength, and tensile strength of scaffold healed versus naturally healed vaginal tissue.

Master Of Business Administration (M.B.A.), Strategy

Master’S Degree, Bioimaging

Post-Baccalaureate Program

Engineering

B.S., Biology