Parkton, Maryland, United States
Biomedical Engineer with Project Management and Process Engineering experience relevant to pharmaceutical manufacturing in a cGMP facility. Works on cross-functional collaborations in support of ANDA and 505(b)(2) filing strategies for Oral Thin Film, Mucosal Thin Film, and Transdermal Patch dosage form technologies. Excellent communication, strong interpersonal skills, flexibility and adaptability to drive project needs/goals.
Served as Pharmaceutical Development SME for ARx with detailed understanding of FDA and QbD requirements with respect to Thin Film and Transdermal dosage forms. Led and managed projects from formulation development through FDA approval. -Working with project teams, planned and managed key activities consistent with Product Development Process (PDP) through entire life cycle to product launch -Contributed to, reviewed and approved developmental plans and outputs -Served as customer liaison and coordinated activities across functional groups including Sales, R&D, Quality, Engineering, Manufacturing, Finance, Purchasing, EHS, and Legal
Responsible for developing, scaling up, and validating processes used for producing specialty drug delivery products (Oral Thin Films and Transdermal Patch technology) in a manner compliant with 21CFR211 and all other relevant regulatory requirements. Duties: -Prepared and executed experimental and validation protocols for pharmaceutical and chemical processing, coating, and slitting/finishing areas in compliance with 21CFR211 -Generated design records required to support product development and commercial production -Drafted and implemented Change Controls, conducted deviation investigations, and executed preventative actions.
Translational Oncology Solutions using Patient-Derived Xenografts (PDX) Designed, executed, and analyzed studies testing preclinical compounds for pharmaceutical clients using PDX platform. Defined client scientific requirements, developed study design, and drafted protocols according to IACUC guidelines and operational ability. Collaborated with project management team and operations to provide weekly updates, data analysis, and final reports to clients. Interfaced with business development team and finance department using Salesforce to ensure revenue recognition, final invoicing, and documentation for client-sponsored studies.
Department of Radiation Oncology and Molecular Radiation Sciences Project focus was on cancer therapy using magnetic nanoparticle-mediated hyperthermia. Performed experiments in analytical chemistry, tissue culture, bioconjugation, electrophoretic separations, and viability assays. Utilized human tumor xenografts in rodent and rabbit models for experiments. Administered nanoparticle/drug conjugate IV, IP, PO, or IT according to experimental model. Characterized in-vitro and in-vivo cell/nanoparticle interactions using microscopy and spectroscopy techniques. Harvested primary cells, blood, and tissue specimens for metals analysis. Processed and analyzed samples using inductively coupled plasma-mass spectrometry (ICP-MS). Responsible for quality control of radiofrequency alternating magnetic field (AMF) device including maintenance, experimental planning, preparatory setup, calibration, and therapy experiments.