Experience

Verenium...now part of BASF
• United States
• Biotechnology Research
• 1 - 100 Employee
• Scientist

  • Oct 2021 - Present


Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist

  • Feb 2021 - Apr 2021

  Contracted to temporarily fill the shoes of staff absent on maternity leave. - Conducted molecular and cell biology experiments to identify and validate drug targets. Supported assay optimization and validation. - Developed SOPs, WI and performed process validation for the collection and processing of cells, tissues, dosing regiments, and efficacy measurements for in vivo and in vitro assay development initiatives for new projects. - Troubleshooted and analyzed complex data in support of drug discovery projects. Presented results and conclusions both orally & written - Provided proficient mouse in vivo skills including multiple forms of dosing (IP, SC, PO, IV)), blood collection, tissue harvesting, and seamlessly executed in vitro studies including RNA isolation, qPCR,, ELISA, MSD, immunohistochemistry, FACS, multicolored flow cytometry Show less



Self-Employed Contractor

• Business Consulting and Services
• 700 & Above Employee

• Business Development & Quality Manager Contractor

  • Aug 2018 - Jan 2020

  Independent consulting practice providing clients with professional services, software Saas solutions, training and implementation related to Business Development, Marketing, Quality, Environmental, and Organizational improvement. -Contract Offerings include: Quality/Operations Evaluation, Market Analysis, Marketing Strategy & Implementation; LEAN tools reducing cycle time – 5S, process flow, kaizen events, standardize work, and 6Sigma specific applications – automated SPC for precision measurements (angstroms), DMAIC problem solving, -Leadership, consulting and mentorship for Veterans Hospital Administration (VHA), national roll out of ISO 9001 in critical medical operation. VHA is the largest global healthcare system with 8.1 million patients. Show less



Pfenex Inc

• Associate Scientist- Contracted for biosimilar CMC regulatory filing

  • Jan 2018 - May 2018

  Pfenex, a LEAN organization, is a clinical stage development focused on producing improved high-quality vaccines and biosimilars, therapeutic drug equivalent proteins. Biosimilar to Forteo ® NDA filing. •Joined Pfenex to support the NDA filing their injectable biosimilar drug candidate equivalent to Forteo® provided leadership in Quality, Analytics & Compliance with an umbrella of activities. •Supported GMP testing for release and long-term stability programs for drug substance (DP) and the drug product (DP) of Forteo®; giving feedback to the DSP team optimization efforts, and monitoring product quality with investigations of any deviation in accordance QSR with product release documents. •Developed, executed, improved and qualified analytical methods and biochemical characterization activities for in-process biosimilar protein product development such as SDS-PAGE, Western blots, UV-Vis spectrophotometry, ELISAs, and HPLC separation & quantification (RP, SEC, HIC, IEX, USP for drug purity). •Provided analytical results to direct effective purification development, product/process control strategies, ensure successful process manufacturing and successful method transfer to CMO; executing method transfer, testing; release & stability comparative studies. JMP. •Delivered detailed analytical data packages and CMC supporting regulatory documentation required to rationalize setting specifications in: product processing strategies, manufacturing processes, method development for analytics; characterization, stability studies and release specifications. Reported KPIs CQAs. •Authored and executed validation protocols (methods, equipment, raw material, process, supplier, cleaning, calibration), method validation, root cause analysis PFMEA, risk assessments for NCEs, WI revisions, qualification activities (design, component, operational, performance). •Resolved Quality issues CAPA, OOS, NCMR, NCEs deviation/improvement, revisions of SOPs, WI, change orders and change control Show less



Bolt Threads

• United States
• Biotechnology Research
• 1 - 100 Employee

• Analytical Development Lead- Associate Scientist

  • Jun 2015 - May 2017

  Bolt Threads, a Series D funded biotech startup engineering biological systems to create revolutionary new materials and products, like spider silk and biodegradable rubber with an on-site plant for novel in-house manufacturing of engineered materials. Managed 3 reports. • Coordinated with multidisciplinary teams to identify analytical development opportunities for improving understanding of our processes from biology, fermentation, through downstream processing, production and manufacturing. Reported to VP of Quality and Analytics under the COO. •Led analytical development and validated a variety of analytical technologies such as KF, FTIR, HPLC, GC-MS, 2D gels, ELISAs, flowcytometry, protease and lipid assays, and more • Advocated, implemented, got buy-in for a “program” within Analytics to enable faster completion of analytical methods for internal customers, called BATON. •Led start of GLP Quality Department selected a QSM voluntarily ISO/IEC 17025 for accreditation. •Authored QA/QC documents (SOPs), (TMs), determined acceptance criteria, batch reports, product release documents, and CAPA & more •Nominated for Leadership training. 3 month course. •Appointed SME for in-house method development for our new GC-MS •Demonstrated expertise in purification techniques on the AKTA FPLC •Designated DoE expert. Designed and executed DoE studies for fermentation & media optimization, DSP processes, factors affecting the “spinnability” of the fiber. •Appointed in-house expert for JMP license and expert training course. •Monitored in-house tech transfer initiatives with CROs and CMOs led experiments for risk identification, abatement. •Creatively developed a crucial assay, in-house detection reagent that saved the company thousands and achieved monitoring capabilities to reduce this impurity and get to product purity levels required. Show less



Mélange Productions, Inc.

• Co-founder & Cheif Operations Officer

  • Nov 2010 - Oct 2015

  A production company with a mission to celebrate diversity and human rights through the intersection of fashion, technology and the arts. • Concurrent to managing all operations and event logistics, other high level contributions included presentations for VCs, securing the Board of Directors, and sponsor, authoring marketing and PR/media communications, sponsorship packages, sales/financial reports, vendor and participant contracts, established business opportunities, key negotiating role, storyboarding for commercials on NBC and more. •Responsible with co-founder for all financials of the organization, corporate filings, taxes, contracts, shift reports, inventory, approving press releases and orders, training documentation, sponsor relations, branding, marketing, and adherence to mission. Transitioning the company to a 501c3 non-profit organization in 2016 • Produced PR events for clients like IBM (360 Fashion &Tech), Autodesk, and Bossini high-end boutique showcasing the Versace Collection SS 2012 Collection. • Secured $200K incorporate partners/sponsors, including Porsche, NBC, Sephora (4yrs), the SF Regency Center (3yrs), W Hotels, Paul Mitchell, Everything Audio Visual, Yes Style and many others. • Created, launched Melange Kids, increased revenue by 20% for 2014 +ROI. Secured celebrity teacher for the program Katiti Kironde, the first African American woman on cover of Glamour Magazine. • Oversaw international productions in 3 Brazil cities as part of pre-World Cup Festivities sponsors Hall of Rio de Janeiro, W Hotels, MAC. Returned for Olympics. • Led international and virtual teams +20 ensuring operational execution of our annual & international events; often 20+ vendors to bring productions together.. • Proven adaptability in changing priorities, analytical business acumen, operations and logistics critical thinker, skilled developing strategic partnerships, persuasion sales, maintaining composure & leadership under pressure, keeping it fun. Show less



GeneWeave Biosciences

• R&D Assay Development Lead- Associate Scientist

  • Mar 2013 - May 2014

  An In Vitro Diagnostic company with a novel assay technology creating a new medical device system to detect bacterial pathogens with bacteriophages in a luciferase gene reporter assay system. BSL2, GMP, FDA/EU , CFR, QSR/ICH/ISO 13485 environment Reported directly to the CTO and to the VP of Product Development and Operations. Project Management/Automation Engineer: Managed and executed their first Automation Pod crucial to reporting the assay coverage on 100’s of MRSA, MSSA variants to the FDA; requiring engineering skills, learning Python, incorporating IQ,OQ,PQ; regulatory compliances guidelines BSL2, GMP, CFR/ISO/FDA Key Contributions as the Assay Development Lead for R&D: Optimized the bacteriophage concept assay, transition the assay from POC to to viable product with DoE . Managed the creation of the IVD SmarticleTM Reagent Kit ensuring in compliance with QSR and FDA regulations. Led exploratory investigations for newly proposed projects to increase the pipeline and proved transformation of technology into other industries supporting intellectual property filings. Led in-house mock clinical trials. As project manager, with CTO and stakeholder input, created criteria for decisions escalating projects to programs. Reported the feasibility of early stage projects and the progress, timelines, challenges and solutions of current projects. Nominated BioSafety Officer for BSL2. Implemented/enforced, documented occurrences, training. Responsible for bacterial pathogen inventory of variants. • Bridged R&D and product development s. • Leveraged project management techniques, tools, and software to develop full scale project plans, predict resource allocation, maintain project timelines, and meet deliverables. • Maintained, monitored and helped standardize Quality System Regulations, Design Control: ISO, and FDA regulations. Show less



Codexis

• India
• Mining

• Senior Research Associate

  • Jun 2008 - Nov 2012

  A green chemistry company engineering industrial organisms to produce target enzymes useful for biofuels, pharma applications, and other environmentally friendly products. • Developed and validated a new technology and prototype, and performed the milestone experiment/demonstration for the customer, directly leading to $1.4M milestone payment for Codexis. • Advocated, introduced, and implemented new in-house technologies: Developed specialized 2D gels for protein expression monitoring. Developed partnership for out sourcing amino acid sequencing. Implemented ELISA assays. Created a protease assay panel to quantify and identify proteases in fermentations of multiple expression systems. • Recipient of 4 employee recognition awards (only given bi-yearly) for implementing new in-house technologies, milestone achievement contribution, and project successes. • Designed, performed and implemented model experiments to evaluate new ideas, give feedback and predict large scale production. Identified downstream challenges and scientific problems early, suggesting new approaches and solutions. • Lead assay development project lifecycles; from concept to development, validation, optimization and transitioning to a commercial product or a robust internal assay for HTP screening • Collaborated on diverse, multi-disciplinary teams to monitor strains and enzymes engineered and presented, documented and shared information of project lessons learned. • “Super user” of robotics and automation equipment. Expertise in programming, troubleshooting and validating robotic equipment. Mastered and implemented DoE methodology for synergy experiments. DoE and leadership training. • Leveraged and used a broad range of R&D and QC resources, equipment and techniques throughout a project’s lifecycle including HPLC, GC-FID, GCMS, M5 spectrophotometers, BioMek Nx and Fx, Tecan, and more. • Participating member of the emergency response team. First Responder Awareness certified. Show less



University of California, San Francisco

• United States
• Higher Education
• 700 & Above Employee

• Research Associate

  • Jun 2005 - 2008

  • • Investigated the cellular mechanisms of angiogenesis, vascular remodeling, and plasma leakage by inducing inflammation in the airways using Mycoplasma pulmonis or lippopolysacharide infection of normal, transgenic (CC10-VEGF), and knockout mice (VEGF-D, CCR2, CCL2, and TNF-alpha null mice) to identify the cells, growth factors, and chemokines that mediate vascular remodeling during chronic inflammation. • Examined the roles and modulations of the immune system during inflammation and tumor angiogenesis by studying blood vessel remodeling pathways, cascading immune cells, and the lymphatic vasculature. • Identified morphologically different lymphatic endothelial cell types and the respective functional roles by describing modulations in lymphatic endothelial cell adherence junction molecules during inflammation. • Experienced with murine Lewis Lung carcinomas, human Colo205 tumors in immuno-deficient mice, and transgenic Rip-Tag2 murine pancreatic islet tumor models. • Performed in vivo and in vitro assays: , tissue/tumor processing primary cell cultures, transfection, purification of immune cell populations, quantitative immunoassays, cell proliferation and toxicity, immunogenicity studies, and more. • ELISA, qPCR, immunohistochemistry, confocal microscopy, FACS flow cytometry, Western blot, • Co-published 2 papers and presented novel findings and results at conferences. • Collaborated with and presented data at project meetings with corporate and academic collaborators, such as Genentech, Exelixis, MedImmune and others. Show less