College Station, Texas, United States
I’m seeking a MSAT, CMC, or Process Development Scientist role at biotechnology and biopharmaceutical companies, and am the perfect fit for this role because I have the following relevant skills: upstream process development, experimental design, quality & process control, problem solving, process validation, tech transfer , KPI - CPV Monitoring & Reporting. I have implemented my expertise in process optimization for integrating Process Analytical Technology (PAT) and real-time analytics, resulting in a 25% improvement in product yield and 15% enhancement in process efficiency through optimized bioreactor performance and feeding strategies. I also have led successful technology transfer from lab to pilot scale, developing Standard Operating Procedures (SOPs) and process control strategies for fermentation and filtration equipment, ensuring GMP compliance and supporting regulatory filings, as demonstrated by establishing over 30 SOPs. Cross-functional collaboration skills and experience working on projects related to advanced process intensification by integrating PAT and real-time analytics for improved control and efficiency, as well as advising QA and facility engineering teams during cleaning validation efforts under cGMP standards, as evidenced by successfully increasing protein expression by 15-35%. Expertise in upstream process development for optimizing cell culture and fermentation processes for biologics, mAbs, and vaccines, increasing product yield, and successful technology transfer to manufacturing scale, resulting in a reduced production cost by 5-10% by reducing batch cycle time 10-20% by improving process consistency across multiple batches. Proficiency in PAT (Process Analytical Technology) and multivariate data analysis, to implement QbD (Quality by Design) principles, leading to enhanced process robustness, leading to a reduction in batch-to-batch variability for cGMP-compliant biopharmaceutical production and attained increased recombinant protein yields by 35% through optimized fed batch fermentation strategies. I want to serve an organization that prizes trustworthiness, accountability and honesty among its employees. I’m excited to be on a team built around learning, diversity and a strong, creative reputation. I know I will thrive at a company where responsibility is valued, as well as fairness and collaboration. I want to be a part of an organization that infuses growth into their brand, culture and market and who I can help make a difference in the world. Please connect with me here: [email protected]
I advice on the Process Validation Cycle of biotherapeutics, serving as the technical bridge between Process Development (PD) and full-scale cGMP manufacturing. My focus is the transition from early-stage development to First-in-Human (FIH) environments. I specialize in ensuring that processes are "Fit for Purpose" for regulated, larger-scale cGMP environments.
• Provided scientific consultation to customers and cross-functional teams, troubleshooting bioprocess design challenges and implementing process improvements, increasing efficiency by 15%. • Developed skills in scientific consultation, and cross-functional collaboration. • Evaluated automation and risks to improve upstream decision-making and production readiness by 10–25%.
My role was to manage upstream process development and tech transfer for biologics and vaccines, leading optimization of bioreactor operations, PAT integration, and GMP-compliant scale-up in a cross-functional setting. My achievements include: • Acted as SME in quality and facilities management, advising QA and engineering on cleaning validation and production readiness. • Assessed 3 scale-up projects (2 vaccines, 1 ADC) across 2- 4 national sites, resolving aggregation and degradation issues to enable IND filling , aligning 7+ cross-functional stakeholders across QA, PD, and MS&T. • Authored and verified 10+ batch records in Veeva Vault, improving data traceability and compliance alignment. • Automated aseptic filling systems, reducing error by 23% and operation time by 53–70%. • Coordinated EHS oversight during construction of veterinary vaccine facility, engaging contractors and experts to meet OSHA and inspection-readiness standards. • Designed DOE-driven studies to optimize bioreactor performance, nutrient feed, and oxygen strategies, enhancing process efficiency by 15%. • Guided ADC purification development, advising chromatography steps and defining UF/TFF harvest and clarification parameters, reducing development timelines by 8 -12 % and process times by 34 – 40 % . • Integrated PAT and analytics tools to increase product yield by 22% and support in-process protein characterization (concentration, aggregation, pH). • Investigated recurring cell culture contamination, tracing root cause to procedural gaps, and implementing mitigation protocols and staff training that reduced recurrence by 82 – 87 %. • Standardized electroporation parameters for viral strain development in BHK cells, optimizing RNA input and pulse settings to streamline virus expression workflows. • Verified SAP-based procurement workflows, reducing material delays 4 – 7 % and supporting uninterrupted bioprocess operations.
My role was to plan early-phase bioprocess development and upstream optimization, focusing on bioprocess scalability, fermentation strategies, and GMP-compliant documentation for regulatory support. My achievements were: • Authored 30+ SOPs and batch records for GMP compliance; led training on process design and troubleshooting. • Evaluated nutrient depletion and developed dense-feed formulation, reducing degradation by up to 10% while balancing biomass and protein yields in yeast expression systems. • Implemented IQ/PQ validation protocols for M&O Perry vial filling system, ensuring GMP readiness for aseptic drug product operations. • Increased CHO cell viability by 15% and phage yields by 20% through improved upstream controls, metabolic profiling and osmolality monitoring. • Mentored junior scientists and engineers on upstream development and automation, reducing error rates and improving protocol adherence by 20%. • Optimized fed-batch and pH control strategy in yeast systems, boosting protein yield by 30% in under six . • Performed scale-down fermentation studies for yeast-based ADC to verify tech transfer readiness, identifying yield-limiting process gaps, and adjusting parameters to ensure successful operational fit onsite.
In this role, I partnered with cross-functional teams at this workforce education center to deliver technical expertise and professional development for the biopharmaceutical industry. This included creating a curriculum for upstream biomanufacturing and cell therapies, cell culture techniques, and scale-up principles. I trained the technical staff on fermentation operations, monitoring, and controls, various aspects of cell culture, and downstream processing of biological materials such as viruses, monoclonal antibodies, and other recombinant proteins. My achievements include: • Configured lyophilization parameters and freeze cycles for client stability testing, enhancing protocol readiness for tech transfer. • Delivered bio manufacturing training to 100+ professionals, enhancing workforce readiness for emerging bioprocessing technologies. • Designed serum-free adaptation protocol for adherent CHO line, reducing suspension transition time by 20% through stage media modulation. • Determined optimal depth filter train for antibody clarification, reducing host cell protein burden by 13–25% and improving downstream chromatography efficiency. • Evaluated Tecan for high-throughput resin screening using Robocolumns, reducing hands-on time by 22 %. • Identified critical process parameters to maximize toxic proteins expression using DoE and statistical modeling, increasing protein yield by 18%. • Increased recombinant monoclonal antibodies and nuclear proteins yields by 30 - 33% through process controls and fed-batch optimization. • Led CHO microcarrier screening based on attachment efficiency, increasing cell seeding accuracy by 15% through matrix optimization.
In this position, I applied a sound scientific methodology to separate and characterize metabolites via HPLC, gas chromatography, mass spectroscopy, and nuclear magnetic resonance for research and development. I interfaced with cross-functional teams to analyze enzymatic expression levels by measuring activity with colorimetric assays and zymograms. I also drafted proposals and secured funding for the university’s National Science Foundation (NSF). By implementing processes and procedures, I spearheaded proteomics analysis of fungal catalysts in the lab and adapted protein extraction methods for fungal systems. I communicated with diverse, non-technical audiences. My achievements include: • Increased product yields from 11% to 35% through system approach optimization. • Improved extraction yields from 60% to 85% via batchwise stage extraction with a mixture of solvents. • Mentored two undergrads and two high school students in a three-month project, enhancing their critical thinking and analytical skills. • Standardized analysis and protocols for fungal proteins and natural products extraction to facilitate effective studies.
Senior Chemical Design ► Assured student’s designs were inherently safe and feasible. ► Familiarized students about the new OSHA’s globally harmonized system of classification and Labelling of Chemicals, GHS
Thermodynamics ► Provided academic support to 250 students through comprehensive step by step problem solving ► Detected areas where students had more difficulty understanding and suggested alternative ways to facilitate there learning.