Nikolas Orozco Email & Phone Number

San Diego, California, United States

San Diego Metropolitan Area

• Reagent development support, validation, and transfer: separation of protein drug candidates, development of formulations recipes, peptide mapping, and oligo synthesis.
• Participated in cost saving initiatives, effectively saving the company over a million in scrap material while improving efficiencies.
• Designed, developed, and implemented optimized analytical chemistry assays and methods successfully to support incoming projects and sustainability reducing turnaround times to half with an emphasis to robustness to.
• Validated testing methodology used in raw materials, production intermediates, and final products for Research and Operations departments, effectively promoting team’s value and resources by 30% companywide.
• Evaluated product lifecycle management support via analysis and evaluation of material and products, improving shelf life with overall reduction of preliminary scrap by 20%.
• Performed project management of interdepartmental (cost saving, sustainment) and external (novel reagents/ oligos/enzymes) project timelines to successful completion.

San Diego, California, United States

• Developed and evaluated analytical methods to characterize critical components of NGS consumables. Represented Method Development and Transfer (MDT) department in cross-functional teams for new projects.
• Validated and tech transferred 10% of all analytical methods to Manufacturing and QC laboratory.
• Performed data analysis and troubleshooting of aberrant results and made technical recommendations as SME (Subject Matter Expert) improving quality and accuracy of results and reports, saving additional time and.

Greater San Diego

• Lead Analytical Scientist who performed novel studies, routing testing, provided consultation to clients and drove presentations/meetings. Supported multiple projects simultaneously while providing coverage for.
• Developed innovative solutions for technical problems by increasing efficiencies in instrument errors/line down systems as well as assisted in the implementation of new technologies expanding technical expertise into.
• Guided and mentored junior staff to successfully complete projects and grow technical knowledge.

Greater San Diego Area

• Interacted with clients, conducting one-on-one meetings and data presentations.
• Project management and organization of multiple projects including novelty drugs, clinical studies, characterization studies, Real-Time Stability or Accelerated Shelf Life studies, and more.
• Time management and optimization of project specific work reducing turnaround times by 20%.
• Leader in several areas such as: Empower software, HPLC troubleshooting, notebook and data setup, client-project guidance, and training resulting in high success rate in project completion/ timelines as well as the.

Greater San Diego Area

• Managed sample and data preparation and entry for GLP and GMP compliant projects in quantitative and qualitative chemistry department. Complied with FDA cGMP documentation and laboratory regulations including.
• Organized and executed stability projects and time points of those projects.
• Developed preformulation and formulation of API’s for various reagents, injectables, tablets/capsules resulting in project progression into phase appropriation studies.
• Analytical testing of such API’s and method development for GMP projects.

Greater San Diego Area

• Reviewed and approved controlled documents such as protocols, test methods, master batch records, and specifications. Checked executed batch records and analytical release and stability data.
• Performed internal audits and supported external and client audits enhancing successful performance and compliance.
• Reviewed TOC cleaning procedure for equipment as well as other various cleaning verifications, ensuring and preventing cross-contamination of products.

Carlsbad, California, United States

• Manufacturing Associate
• Operate and maintain bioreactors 10L, 50L and 250L
• Assist in setup and cell culture expansions
• Perform various processes using aseptic techniques
• Responsible for Media formulation/preparation, freezing, thawing and testing
• Manual / Automated Cell Counting, expansions and harvest