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Tamara C Tamas

Biopharmaceutical Regulatory Affairs | Clinical Research | Cell Therapy | Translational Science

Background
Education & Publication
Academic Degrees
01
M.S. Biopharmaceutical Regulatory Affairs

Northeastern University — 2024

02
B.S. Chemistry

University of Louisiana at Lafayette — 2014

Peer-Reviewed Publication

A. Odoux, D. Jindal, T.C. Tamas, B. W.H. Lim, D. Pollard, W. Xu (2016)

"Experimental and molecular dynamics studies showed the CBP K1X mutation affects the stability of CBP:c-Myb complex"

Computational Biology and Chemistry. 62: 47–59

Current Role
Director of Clinical Research & Translational Programs

Healing Hope International — Nonprofit Organization  |  04/2024 – Present

International Programs

Leads observational and outcomes-focused studies in traumatic brain injury, hypoxic-ischemic encephalopathy, and immune modulating therapies.

Regulatory Oversight

Oversees clinical trial registration, protocol development, and PRS review on ClinicalTrials.gov, ensuring compliance with international ethical frameworks.

Translational Science

Directs cross-border initiatives in regenerative medicine, neurorestoration, and translational biologics with a focus on real-world evidence generation.

Observational Design

Designs and manages study frameworks to evaluate safety, functional outcomes, and longitudinal recovery in neurologic injury populations.

Previous Role
Cell Therapy Associate

KBI Biopharma  |  03/2022 – 04/2024

cGMP Manufacturing

Manufactured cell therapy products per batch records using aseptic techniques for cell culture feeding, expansion, counting, and cryopreservation in a cleanroom environment.

Documentation & Compliance

Documented manufacturing procedures, line clearance, and cleaning per Good Documentation Practices. Contributed to non-conformance, deviation, and CAPA documentation.

Biobanking & Equipment

Managed biobanking, seed material dispensation, and finished product accountability. Performed equipment maintenance per SOPs.

Early Research Experience
Clinical Research Internship

Pennington Biomedical Research Center — 9/2014–12/2014

Conducted pre-clinical trials on adipose tissue calculation accuracy using ultrasound, near-infrared interactance, and bioelectrical impedance. Researched lifespan impact of artificial sweeteners on C. elegans under Dr. Jolene Zheng. Received HIPAA, CITI, and Ethics certifications.

Biochemistry Research Assistant

University of Louisiana at Lafayette — 8/2013–12/2014

Conducted independent projects on protein interactions via bacterial and yeast transformation. Modeled CBP:C-Myb complex bonding. Trained students on plasmid isolation, restriction digestion, DNA recombination, and spectrophotometric analysis.

Inorganic Research Assistant

University of Louisiana at Lafayette — 8/2012–6/2013

Synthesized a ruthenium-based metallopharmaceutical for anticancer research using reflux and distillation. Applied atomic absorption spectroscopy, gas chromatography, and ion-selective electrodes for chemical analysis.

Administrative & Outreach
Chemistry Department Assistant

University of Louisiana at Lafayette  |  8/2012 – 12/2014

Database Development

Built an Access database with Visual Basic to maintain records of ~4,000 chemicals across the department.

Records & Outreach

Updated 20 years of alumni contact records and managed social media for department community relations.

Science Olympiad

Conducted fundraising, advertising, and community outreach for Science Olympiad events.

Professional Certificates
Fundamentals of Biomanufacturing

North Carolina State University — 2022

Essentials of biological systems for product development, covering biopharmaceuticals, vaccines, bioprocess engineering, quality assurance, regulatory compliance, and industry innovations.

Biopharmaceutical International Regulatory Affairs

Northeastern University — 2018

International regulatory requirements for safety, performance, and efficacy of biomedical goods, including global commercialization strategies and marketing pathways.

Good Clinical Practice

National Institute of Health — 2017

Covered IRBs, informed consent, confidentiality, participant safety, adverse events, QA, research protocols, documentation, research misconduct, and investigational new drugs.

Career at a Glance

From foundational laboratory science at the University of Louisiana to leading international clinical research programs, T.C. Tamas has built a career spanning bench chemistry, cGMP biomanufacturing, and translational regulatory science.

Core Competencies
Cell Therapy & Biomanufacturing

cGMP operations, aseptic processing, cryopreservation, biobanking, and cleanroom compliance at commercial scale.

Clinical Research Design

Observational study frameworks, protocol development, ClinicalTrials.gov registration, and outcomes-focused research in neurologic injury.

Regulatory Affairs

International biopharmaceutical regulatory strategy, GCP compliance, marketing pathways, and safety/efficacy frameworks for global commercialization.

Analytical Chemistry

Atomic absorption spectroscopy, gas chromatography, ion-selective electrodes, protein modeling, and spectrophotometric analysis.

Advancing Science. Improving Lives.

With a decade of experience spanning academic research, cGMP biomanufacturing, and international clinical program leadership, T.C. Tamas brings a rare combination of scientific rigor and regulatory expertise to every initiative.

M.S. Regulatory Affairs

Northeastern University, 2024

Peer-Reviewed Author

Computational Biology & Chemistry, 2016

NIH GCP Certified

Good Clinical Practice, 2017