Daniel Thrasher Email & Phone Number

North Reading, MA, US

Cambridge, Massachusetts, US

Boulogne Billancourt, FR

• Provide technical expertise on manufacture of commercial liposomal product
• Support quality event investigations triggered by GMP manufacturing deviationso Participate in Unplanned Events, Out-Of-Trend, and Out-Of-Specification investigationso Performing historical data analysiso Leading or.
• Manage and execute Continuous Process Verification program
• Identify risks and gaps to drive ongoing Process Improvement and Development activities
• Writing and review of quality system documentation

Bedford, MA, US

• Performed process improvement and scale-up activities for a pre-clinical implant product
• Optimization of product persistence assay and methods
• Development of in vitro procedures to simulate in vivo results
• Investigated kinetics of drug product / medical device interactions
• Worked with external organizations to develop analytical procedures

Cambridge, MA, US

• Led scale-up and optimization activities to develop targeted nanoparticle formulations for drug delivery of a chemotherapeutic ○ Designed and executed experiments using a Quality by Design approach to optimizing.
• Participated in multiple scale-up/optimization activities of pre-clinical projects ○ Including in-process solution and product stability, in-line/at-line/off-line monitoring, processing reliability, pre-filtration.
• Performed optimization of an existing lyophilization process ○ Investigated methods to reduce overall cycle time, including manipulation of freezing speed, freezing temperature, hold times, primary dry temperature and.
• Maintained ongoing lyophilized material stability studies○ Controlled inventory of in-house stability samples○ Performed analytical assays including: particle sizing via DLS, particle aggregation via SPOS, cake.
• Manufactured testing materials for other departments within the company
• Managed a junior employee, training them and guiding their day-to-day activities

• Worked to improve yield, purity, and ease of scale-up aspects of pre-clinical projects through modification of existing column chromatography methods.
• Optimization of column chromatography methods (affinity, HCIC, IEX)
• Purification of protein for development activities via column chromatography
• Provided expertise on TFF methods
• Contributed to creation of development reports for tech transfer
• Assisted co-op students in their training and education

Lexington, MA, US

• With a focus on TFF and column chromatography, worked to reconfigure a commercial production method to improve cost-effectiveness and decrease total production time. Also assisted in development of pre-clinical.
• Development of improved antisolvent protein crystallization/precipitation methods
• Purification of protein for development activities via column chromatography/TFF
• Optimized chemistry of new generation commercial manufacturing processes
• Quantitative analysis of in-process samples
• Integration of new technologies into department

US

• Utilized a broad variety of methods to assist in optimization of the manufacturing process of a drug candidate (phase 1 through late phase 2), from both a chemical and physical engineering standpoint.
• Optimized chemistry/engineering of clinical manufacturing processes
• Increased robustness of antisolvent protein crystallization process
• Performed experimentation to increase understanding of proprietary technologies
• Qualitative and quantitative analysis of in-process samples
• Supervised interns in their duties

Burlington, MA, US

• Expressed and purified mABs in E Coli at benchtop manufacturing scale as a step in research activites.
• Performed protein expression/purification in E Coli and P pastoris
• Devised optimizations of existing protocols
• Assisted Scientists with experiments
• Maintained chemical and equipment stocks in-lab

Performed environmental monitoring of air, water, and surfaces within manufacturing and research areas using touch plates, bioburden and LAL among other methods.