Daniel Thrasher Email & Phone Number

North Reading, Ma, Us

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 participating in Root Cause Analyses with cross-functional teamo Performing lab-scale or external experimentation• 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 formulations and recipes of ACCURINS with varied physicochemical properties and biological performance ○ Organized and directed activities of four employees on project ○ Defined a robust manufacturing process which conformed to existing clinical manufacturing equipment, and included optimal and acceptable processing zones and points of failure for formulations parameters and manufacturing set-points ○ Collated, edited, and wrote development report on activities● 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, sterile filtration, TFF, filling, and drug product stability● 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 vacuum set-points, and primary and secondary dry ramp speeds.○ Produced a lyo cake visual library for use in manufacturing QC inspections by forcing specific failures (meltback, collapse, etc.) via manipulation of cycle set-points and timing.● 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 reconstitution, and in-vitro release.● Manufactured testing materials for other departments within the company● Managed a junior employee, training them and guiding their day-to-day activities● Trained new employees in a novel manufacturing process● Assisted in defining multiple key optimizations of a novel manufacturing process

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 manufacturing processes.● 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.