Raghava Sriramaneni

Nivagen Pharmaceutical GMP QC Microbiology Reviwer @ Nivagen Pharmaceuticals, Inc.

About

PhD-level scientist with 10+ years of experience at the intersection of GMP QC operations and translational pharmacology from preclinical discovery to commercial manufacturingIn my current role at Nivagen Pharmaceuticals, I execute GMP-compliant pharmaceutical testing including bioburden, endotoxin, sterility, and environmental monitoring, while managing the full lifecycle of quality events authoring and reviewing SOPs, deviations, change controls, and CAPAs within eQMS platforms. I prepare trend data reviews to support continuous quality improvement and maintain robust inspection readiness in alignment with FDA regulations, USP requirements, and cGMP standards My earlier career as a Senior Scientist at CytomX Therapeutics and as a Research Scientist at the University of Wisconsin gave me deep expertise in nonclinical IND/CTA strategy, GLP and non-GLP study design, CRO management, and regulatory document authoring advancing ADC and T-cell bispecific programs to Phase 1 clinical trials. I have authored nonclinical sections of IND and NDA submissions, coordinating across Toxicology, DMPK, and Clinical teams, and have presented scientific findings to senior management and health authorities. This combination of rigorous bench science, translational pharmacology, and GMP quality systems enables me to approach quality assurance with a strong analytical mindset particularly in root-cause investigations, atypical result assessments, CAPA effectiveness evaluations, and cross-functional risk discussions. I am experienced at bridging Research, Manufacturing, and Quality functions, translating complex scientific data into clear, compliant, and actionable quality decisions I hold a PhD in Pharmacology, am a co-first author in Nature Communications, and hold a PCT patent in nanoparticle-enhanced cancer immunotherapy reflecting a commitment to scientific excellence that, I carry into every quality and compliance activity I am currently open to new opportunities in GMP QC, Quality Assurance, Preclinical Development, or roles that bridge translational science and regulated quality operations within the biopharmaceutical industryCore Expertise: GMP QC Operations • Environmental Monitoring • Bacterial Endotoxin Testing (BET) • Investigations & Root Cause Analysis • CAPA Management • Change Control • Deviation Management • SOP Authoring & Review • eQMS • Data Integrity (ALCOA+) • IND/CTA • GLP/Non-GLP Study Design • CRO Management • Translational Pharmacology • ADC & Bispecific Modalities • Inspection Readiness

Country

United States

City

Greater Sacramento

Industry

Biotechnology

Skill

In Vivo experimental expertise (animal models, dosing, surgery, disease models), Data analysis and statistical skills , In vivo pharmacology, PK/PD, Cross-functional Team Leadership, Change Control, Standard Operating Procedure (SOP), Technical Support, Employee Training, Regulatory Compliance, Microbiology, Laboratory Skills, Collaborative Problem Solving, Oncology, ELISA, epidenetics, Obesity Research, Epigenetics, IHC, Pathogenesis

Experience

Nivagen Pharmaceutical GMP QC Microbiology Reviwer

Nivagen Pharmaceuticals, Inc.

2025-4 - Present · 1 yr 6 mos

Sacramento County, CA

Support GMP QC Microbiology activities Perform and oversee water system testing and endotoxin testing Conduct and review bacterial endotoxin testing (BET) and microbiological assays for product and utility monitoring Review microbiology data for cGMP compliance, accuracy, and data integrity Support method validation and method transfer, including protocol and report review Execute and review environmental monitoring (viable and non-viable), including trending and investigation support Author and contribute to deviations, investigations through eQMS, and CAPAs, supporting root-cause analysis Partner with Manufacturing, QA, Validation, and Engineering to support aseptic operations and inspection readiness Manage and review method development and method validation performed at external CROs Support SOP authoring, revisions, and training within the QC microbiology GMP laboratory

Senior Scientist I

CytomX Therapeutics

2024-4 - 2025-3 · 1 yr

South San Francisco, CA

• ADCs, Cytokines and TCBs focusing on target biology and mechanisms of action • study design and execution: Lead and design in vivo efficacy studies to evaluate drug efficacy, PK, PD, and toxicology in relevant disease models. • Administered test agents via multiple routes (PO, IP, IV, IM) and collected and archived biological samples for further analysis • Analyzed preclinical data using PRISM, Study-Log

Scientist II

CytomX Therapeutics

2022-3 - 2024-3 · 2 yrs 1 mo

South San Francisco, California, United States

• Designed and executed in vivo studies to evaluate drug candidates' pharmacokinetic and pharmacodynamic properties for various therapeutic areas. • Managed a team of in vivo pharmacologists, guiding experimental design and data analysis. • Processed IHC tissue samples for staining and biomarker analysis in both frozen and FFPE In Vivo samples.

Scientist

University of Wisconsin-Madison

2016-1 - 2022-3 · 6 yrs 3 mos

SMPH Human Oncology

• Led in vivo pharmacology studies supporting ionizing radiation with an immunotherapy combination approach in mouse models. • Managed the histology team processing clinical samples using Akoya and Visiopharm platforms. • Analyzed data with GraphPad Prism, Akoya Inform, Visiopharm, and R statistical software for project communication.

Postdoctoral Research Associate

University of Illinois College of Medicine at Peoria,

2013-4 - 2015-12 · 2 yrs 9 mos

Peoria, Illinois Area

Performed rat survival surgeries, such as a stereotactic mouse and rat brain surgeries to implant cancer cells orthotopically to study brain metastasis. Mouse colony management, Morris swim maze, behavioral study, SDS-PAGE, and ELISA. Led the expansion and transition of a computational group to include a fully functional lab. and new laboratory set-up by coordinating with the principal investigator and team members.

Research Fellow

USM

2009-10 - 2013-3 · 3 yrs 6 mos

Penang, Malaysia

• Managed PK/PD, acute, sub-acute, and chronic non-GLP toxicity studies on small molecules like Andrographolide, 14-deoxy andrographolide using rat models. • Conducted experiments on STZ induced type 1 diabetic mouse models and obesity induced type 2 diabetes mouse models. • Prepared and analyzed flash frozen and FFPE preclinical test samples for publication reports.