Greater Boston
Experienced Scientist with a demonstrated history of working in the pharmaceuticals industry.
Primary responsibilities include developing solid, suspension, and/or liquid formulations to be used in drug-device combination products. Optimization of solid formulations for tableting on either a manual or automatic press. Automatic tablet press maintenance and troubleshooting. Conducting lab scale characterization experiments to support formulation, device, and combination product development. Developing protocols, SOPs and work procedures. Preparing technical reports that may serve as source documents for regulatory submission and/or inspection. Author discreet sections of regulatory submissions as needed. Manually assembling prototypes of drug-device combination products as part of product design and development activities. Performing data analysis and generate technical reports and presentations. Developing and accessing manufacturing processes for drug constituent. Contributing to the development and assessment of manufacturing processes for the combination product. Supporting nonclinical and clinical supplies manufacturing activities. Assisting in managing external organizations contracted for drug constituent formulation and analytical development and manufacture of drug constituent for clinical supplies. Also, actively participating in cross-functional product development projects for next generation designs.
Developing analytical methods to characterize the chemical, physical, mechanical and functional performance of products. Performing analytical testing using instrumentation such as HPLC, LC/MS, UV-Vis Spectrophotometer, Instron, and DVS. Conducting lab scale characterization experiments to support formulation, device, and combination product development. Manually assembling prototypes of drug-device combination products as part of product design and development activities. Preparing technical reports that may serve as source documents for regulatory submission and/or inspection. Following established SOPs as well as developing new SOPs and protocols. Assisting in troubleshooting analytical equipment and methods. Assisting in managing external organizations contracted to assist with analytical development.
Responsible for providing analytical support for research and development activities, as well as testing of non-clinical and clinical trial materials to support stability studies. Method development of new HPLC methods (Waters and Agilent Chromatography systems) to facilitate the collaboration of TARIS Biomedical with Active Pharmaceutical Ingredient (API) producers. Rapid HPLC methods used for In Vitro Release (IVR) of new drug substance systems. Other duties include daily sampling of IVR systems, tubing assembly construction, HPLC troubleshooting, instrument method streamlining, and solution stability evaluations.
Responsible for performing chemical testing of raw materials, intermediates and finished product in support of process research, discovery research, cGMP production and stability testing. Prepared method development and generalized process development. Responsible for utilizing common analytical techniques such as: HPLC, GC, KF, FTIR, NMR, Heavy Metals, Residue on Ignition, and titrations for general acid content and Normality. Subject Matter Expert in all QC testing methods.
Responsible for in process and release testing of Protein A products. Conducted Validation and Qualification of new equipment including an FTIR and a pilot scale Chromatography skid. Testing methods included: HPLC analysis for Purity/Binding values, ELISA, Endotoxin using both LAL and Gel clot methods, SDS Page, IEF, Bioburden, and Environmental Monitoring. Responsible for the release testing of OPUS chromatography columns (pilot scale columns) and Subsequent Bioburden and Endotoxin testing. Subject Matter Expert in all QC testing methods and reviewer for QC Analysts.
Responsible for performing and reporting results of analytical tests to support manufacturing, compounding and validation. Conducted specification investigations, reported findings to the QC Supervisor and performed standard product preparation and evaluation per procedures. Reviewed the testing documentation generated in the lab by other technicians and performed tests based on consumer complaint samples. All EPC safety, GMP, and Lean 5S policies and regulation guidelines were used at all times. Chemical identification techniques such as FTIR, UV/VIS, HPLC and GC were used. SAP used for sample receipt and results documentation.