Nicholas Ramirez Email & Phone Number

New Brunswick, NJ, US

Somerset, NJ, US

Somerset, NJ, US

• Lead and develop a team of biomanufacturing associates to execute cGMP production of protein therapies
• Coach and help staff achieve their potential through 1:1 and group meetings
• Manage issues and lead technical discussions with team and supporting departments to ensure successful process execution
• Drive team to monitor production schedules, anticipate risks, and establish solutions to deliver on manufacturing objectives
• Create a culture of lean management and continuous improvement through use of visual control boards, leader standard work, and a focus on processes

Somerset, NJ, US

Somerset, NJ, US

• Developed organizational leadership and technical abilities from 3 8-month rotations across Catalent
• Led Kansas City, Oral Solid Dosage, site-team in Global Cost of Poor Quality project assessing financial and quality management system data using lean six-sigma methodology
• Identified with combined site-teams $1.3 M in cost reduction projects out of $10.2 M in potential opportunities from 5 pilot sites in 3 business units

Somerset, NJ, US

• Led a team of site and Cell & Gene Therapy business unit leadership to implement New Product Introduction Excellence—a stage-gate system for project execution, risk management, and quality-by-design assurance—at BioPark
• Collaborated with senior project manager to manage process development, analytical development, technology transfer, and clinical supply contracts for two high-value gene therapy clients
• Led client internal and external meetings, managed and mitigated project risks, and exercised financial PM responsibilities

Somerset, NJ, US

• Collaborated with senior scientist on Madison’s first Fast-to-Patient mAb platform project aimed at reducing process development timelines
• Executed process development at bench-top and pilot scales using AKTA Avant, Ready, and Process systems and industry-standard clarification, viral filtration, and TFF equipment
• Implemented an automated sample submission system using Power Automate for PD analytical support
• Designed a downstream prior-knowledge dashboard using Power BI, leveraging data from 20-plus executed projects, and exercising Python and Power Query skill sets
• Performed a Principal Components Analysis in Python on a column life cycle dataset to gain insight into the predictors of column failure

Somerset, NJ, US

• Led automated cell culture perfusion implementation in Upstream GMP Manufacturing
• Managed CAPEX request, material & equipment orders, PROFIBUS-DP network installation, DeltaV module creation, automated pump-skid construction, engineering documentation, Ready-to Execute activities, water run.
• Delivered on consistent bioreactor weight and permeate flow control for 4-day N-1 perfusion process
• Authored upstream batch records and contributed PI Process Books data analysis to daily meetings and investigational reports across multiple clients

New Brunswick, New Jersey, US

• Provided campus tours, sat on student panels and represented the Rutgers School of Engineering at public events

New Brunswick, New Jersey, US

• Valued member of group investigating conserved residue mutations on modular cellulase enzymes for use in production of biofuels
• Developed a high level of technical expertise in protein engineering and microbiological lab methods
• Overcame complications in recombinant DNA production through application of new-to-lab cloning techniques; succeeded in generating a recombinant DNA library for subsequent transformation and expression in E. coli
• Optimized and executed end-to-end workflow for expression and purification of a recombinant protein library
• Identified key binding residues critical to cellulase activity via design of binding and activity assays on cellulosic substrates

New Brunswick, New Jersey, US

• Diagnosed and remedied diverse network, software, and hardware issues through troubleshooting and on-the-job learning
• Exercised excellent customer service abilities to ensure patron satisfaction in the computer labs
• Awarded March 2019 Consultant of the Month for diligence and proactivity in delivering quality customer service

Greater Chicago Area, IL, US

• Led research investigating process and basic formulation factors critical to the production of a novel candy product
• Validated and applied analytical tools that effectively tracked key but difficult to measure molecular transformations occurring in candy production process
• Interpreted experimental data to deliver recommendations broadening ingredient flexibility for region-to-region price, regulatory, and process needs
• Worked with a cross-functional and multidisciplinary team to accomplish project objectives within a limited time-frame

• Designed a digital client filing system for ease of document access
• Communicated with various state and local public institutions on behalf of the office

Cedar Rapids, IA, US

• Built immediate rapport with Rutgers alumni through a friendly and engaging attitude
• Secured donations to various Rutgers funds, including departments, libraries, and scholarships

Bachelor'S Degree, Chemical Engineering

High School Diploma