Balu Easwaramoorthy

Head of Quality Assurance

About

Pharmaceutical professional with 15+ years’ experience in cGMP operations and Quality/Regulatory work for small molecules, peptides and biologics. CMC expert for pre-clinical, all clinical phases and commercialization. Proficient in product/process development, QC/QA, technical aspects of cGMP operations, process/product validations, aseptic processing, and supply chain. Proficient to interact with the regulatory authorities such as FDA, ICH, EMA, DOH, DEC, OSHA, Fire Department and NRC. Possess outstanding knowledge of FDA regulations including USP 823, 21CFR210, 21CFR211, 21CFR212, and ICH guidance, and business development. Specializing in the field of oncology, neuroscience and cardiology. Employed and trained at prestigious universities, including Columbia University, the University of Oxford, and the University of California. Professional background encompasses 13 years of managerial duties, including budgets, contract manufacturing operations, business decisions, project and business management, strategic planning, and technology transfer. Practiced assessing emerging data against aspirations and brief senior management on project risks. Skilled for successful NIH grants, business plans, statement of work, and requests for proposals.

Country

United States

City

New York City Metropolitan Area

Industry

Pharmaceuticals

Skill

Radiopharmaceuticals, Oncology, Biopharmaceuticals, Pre-clinical Studies, Clinical Trials, Medical Imaging, Drug Discovery, Life Sciences, HPLC, Organic Chemistry, Organic Synthesis, Biotechnology, Analytical Chemistry, Project Management, Marketing Strategy, Validation, R&D, Cancer, Molecular Biology, Science

Experience

Head of Quality Assurance

Eckert & Ziegler Radiopharma Inc

2022-10 - 2025-9 · 3 yrs

Wilmington, MA

Responsible for planning, coordinating, and reporting of all activities necessary to meet internal and external quality assurance and regulatory requirements for the company’s facilities, audits, validations, products, and services. Lead cross functional teams and represent the Quality unit. Lead risk management, event investigations, change control, root cause analysis and CAPA. Read, analyze, interpret and communicate documents, technical procedures and governmental regulations. Manage and perform audits. Quality documentation for clients IND and GMP compliance.

Director, CMC, Regulatory and GMP operations

NCM-USA

2017-5 - 2022-8 · 5 yrs 4 mos

Bronx, New York, United States

Established lab for IND products, attracted external clients, and led several radiopharmaceuticals and radioligand therapeutics drugs from pre-clinical through all the phases of clinical studies. Executed cGMP operations and CMC regulatory documentations for the Quality sections in eCTD, which includes small molecules, peptides and biological drugs. Translated the regulatory mandates into practical, workable plans to prepare quality section to deliver the early stage and late stage drugs. Be responsible for scientific strategy, processes/analytical developments, validations, FDA filing, audits, APIs and DP manufacturing, quality control and quality assurance, and drug release. Train and supervise the team of 6-8 members. 10+ IND approvals. 1 NDA and 1 BLA approvals. Internal drugs filing and operations: Co-led three ANDA approvals, 18F-FDG, 18F-NaF, and 13NH3. Led the early stage development to obtain FDA approval for Zirconium-89 (89ZR) Oxalate solution (Drug Master File number 28783). Led IND approval for 68Ga-Dotatoc for neuroendocrine cancer imaging. Performed a conceptual to IND approval for cyclotron produced 68Ga and 68Ga-PSMA (NIH exploratory funding). External drugs filing and cGMP operations (CDMO role): Led the Alzheimer drug, TAUVID™ (IND and NDA). Led 131I-Iomab-B (Leukemia) IND and for BLA submission. Other IND approvals include, 18F-AV133 (Neuroscience), 18F-rhPSMA-7.3 (prostate cancer), 225Ac-Lintuzumab (Leukemia), 177Lu-PSMA-617 (prostate cancer), 68Ga-PSMA (prostate cancer) and 225Ac-J591-mAb (prostate Cancer).

Senior Radiochemist, CMC, Regulatory and GMP operations

NCM-USA

2013-2 - 2017-4 · 4 yrs 3 mos

Bronx, NY

Assistant Professor

Columbia University

2008 - 2013 · 5 yrs

Led a four-member team of chemists and engaged in research and development, preclinical and clinical studies. , Oversaw cGMP manufacturing, quality control and quality assurance, and drug release of IND drugs. Led two IND, 11C-FLB-457, and 11C-PHNO, approvals in the neuroscience filed. Member of the Columbia University Radioactive Drug Research drug approval committee. Awarded with the prestigious NIH grant in neuroscience to develop a PET imaging drug to study dopamine D1 receptors.

Research Scientist

UC Irvine

2004 - 2008 · 4 yrs

Led and participated in GLP/GMP manufacturing and quality control of clinical drugs. Co-authored the CMC section for the 11C-PIB for a proposed Alzheimer diagnostics drug. Researched, developed, and introduced a novel radiopharmaceutical for nicotinic receptors.