Abraham (Bram) Verdoes Email & Phone Number

Charlotte, Nc, Us

Lead project planning for all small molecule, biological, and clinical R&D projects including new drug applications (NDA) and abbreviated new drug applications (ANDA), encompassing both internal synthesis and external contract manufacturing. Lead project planning and timeline communication for multiple sterile pharmaceutical products simultaneously.Created work breakdown structures and planning documents using MS Project among other tools.Presented departmental leadership with plans for resource leveling to optimize departmental personnel assignments, leading to increased project speed.Identified process improvements to create business value and then led cross-functional teams to formalize them.Lead project kickoff, huddle, and retrospectives meetings consisting of multiple departments along with both internal and external stakeholders.Identify key KPIs, create reports and dashboards to monitor performance in VeevaManage projects from pre-formulation through process performance qualification batch production.Presented project updates to senior staff and executive leadership. Delivered feedback to functional leadership on project team member performance.

Bloomington, Indiana, United States

Hired to plan and implement two concurrent multi-year NIH consortium projects. Each project involved coordination of 20+ academic teams and external industrial partners spanning three continents, with CNS work accounting for $1M in grants. Project Highlights: Human BioMolecular Atlas Program - Served as Project Manager for HuBMAP, an ongoing project designed to create ways to combine many large datasets for analytics and visualization by researchers. Managed release for the fourth version of Human Reference Atlas, a core HuBMAP component that provides a high-resolution 3D view of much of the human body’s 37 trillion cells. Managed creation of previews for upcoming product releases (sample).Facilitated weekly meetings for content creators (medical illustrators, scientists) to ensure on-time delivery.Liaised to software developers to provide requirements and ensure on-schedule code releases. Kidney Precision Medicine Project - Served as Project Manager for KPMP, a multi-year greenfield collaborative project with multiple research institutions studying kidney disease by developing kidney maps to identify key markers for kidney disease.Facilitated initial kickoff meetings, served as sole CNS representative in additional meetings, and coordinated project information flow into CNS via BaseCamp and Asana.Managed project onboarding to the institutional review board to enable CNS to access sensitive health data.

Hired to manage R&D projects and communications strategies for new medical devices and laboratory consumables within a regulated environment, including supervision and coordination of external contractors. Guided work of a three-member lab team. Managed development of a sputum processing system from initial concept phase through on-site customer demos. Coordinated clinical trials for new IVD devices to GxP standards, held design review meetings, and authored laboratory portions of design history files and regulatory filings.Coordinated projects with external suppliers including Contract Research Organizations (CROs), Contract Development Manufacturing Organizations (CDMOs), and Contract Manufacturing Organizations (CMOs).Managed V&V testing for a new cytology stainer and created regulatory documentation for market launch. Coordinated with marketing to create a white paper for customers. Identified gaps in documentation, defined workflow to prioritize tests based on business needs, guided test teams, and orchestrated sharing of information with multiple departments. Performed annual reviews and hiring of staff, planning for BioEngineering department, and managed $1M+ budgets. Led efforts to modernize the reagent stability program (>$4M ARR) to ensure compliance with Good Laboratory Practice (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practice (GMP) standards.Authored technical documentation (e.g. master batch records, specifications, analytical test methods, stability protocols/reports, validation protocols/reports, change controls, design controls, white papers) for regulatory filings and marketing in collaboration with other departments.Initiated and executed process changes and improvements in the BioEngineering department and developed SOPs including relevant safety, policy, testing, and laboratory procedures.

Greater Salt Lake City Area

• Managed analytical projects from start to completion• Developed and validated FDA compliant analytical methods• Wrote analytical validation protocols and reports complying with 21 CFR Part 11• Responsible for instrumentation maintenance and qualification• Created testing plans and experimental designs for research projects• Supervised direct reports in both an office and laboratory setting

Greater Memphis Area

Duties included developing analytical processes for characterization and quantitation of cellulose polymers through the use of gas chromatography, liquid chromatography, light scattering, and x-ray diffraction. Operated and maintained advanced analytical equipment (e.g. Agilent 7890 and 7697 gas chromatography and Panalytical XPert Pro x-ray diffraction instrumentation). Setup and lead off site visits to evaluate instrumentation, presented data findings and prepared budget proposals related to new equipment purchases. Actively incorporated knowledge from professional trainings (e.g., statistics and experimental design) and current scientific literature to ensure best practices were followed in the workplace. Worked to improve accuracy and resolution of laboratory chemical tests. Lead audits evaluating testing procedures in other departments to improved processes, presented results and evaluated changes. Consulted with other departments to help troubleshoot testing procedures leading to improved performance and results. Ordered laboratory supplies and maintained a well stock, clean laboratory environment.

Bloomington, Indiana Area

Part of a team responsible for sample analysis and testing to ensure on schedule batch release to clients. Examples of testing included sample potency, visibility, color, trace metal, and endotoxin analysis. Laboratory was an FDA regulated good manufacturing practice (GMP) and good laboratories practice (GLP) facility with an accredited quality system and had chain of custody requirements. Used standard operating procedures (SOPs) to perform testing, participated in SOP document creation, change and validation. Used lean laboratory (5S) practices to continuously improve laboratory efficiency and results. Worked with other departments to validate and transfer new methods to the quality control department.

Bloomington, Indiana Area

Part of a team conducting a stability study for a syringe drug product. Responsible for analysis at defined time points using USP compliant tests for potency, particle and dust counts, microbe growth and pH among others.

Bloomington, Indiana Area

Held scheduled sessions for students enrolled in organic and general chemistry courses. Provided differentiated instruction to students according to individual learning styles and strengths.

Bloomington, Indiana Area

Duties included conducting weekly lectures, designing problems sets, supervising chemistry laboratories, administrating and grading course examinations, and maintaining good communication with students and faculty. Courses thought included: organic chemistry lecture, organic chemistry laboratory, and general chemistry.

Master Of Business Administration - Mba, Business/Managerial Economics

Master'S Degree, Chemistry

Activities and Societies: Chemistry Graduate Representative CommitteeConducted research and completed a Master’s thesis project developing.

Bachelor'S Degree, Chemistry, Economics

Activities and Societies: Rugby, Chemistry Society

High School Diploma

Professional Education Short Programs, Design And Analysis Of Experiments

Course content included experimental design, data collection methods, as well as hypothesis testing and data analyses procedures. Specific.