Brian Michaels Email & Phone Number

Cambridge, Ma, Us

Cambridge, Ma, Us

Utilizes MALDI-TOF MS to support impurity characterization and structural elucidation of oligomer-based therapeutics. Identify and onboard instrumentation to aid in process understanding. Develop methods to identify in-process and drug substance analytes. Includes HPLC, GC-MSD, and Ion Chromatography. Optimize or adjust previously developed methods to serve a new analytical need or increase throughput. Organize results in reports and presentations to communicate findings and project direction.

Responsible for simulated intestinal fluid, simulated gastric fluid, and human feces stability data collection for small molecules. Reviewed analysis performed on LCMS. Safety representative for DMPK group. Conducted analysis of biological materials for small molecules in PK studies. Matrices include plasma, whole blood, feces, urine, and other tissues. Monitored preclinical formulation development for lead compounds for use in PK, PD, and Toxicology studies. Evaluated stability and homogeneity of compounds in formulation vehicles using HPLC. Concentration levels and time points vary depending on the study the data supports. Studied stability in human liver microsomes, S9, and A0 to support to metabolite identification of small molecule candidates. Created and updated protocols for assay instructions.

Cambridge, Ma, Us

Support development and production of small scale formulations for research departments. Formulations are primarily used in PK/PD evaluation. Formulations are developed for small molecule APIs primarily using water base and tested for chemical stability. Test solubility and dissolution of small molecules in biorelevant media for use in modeling software. Method development with HPLC, pION, and Covaris AFA to create faster turnaround on solubility studies and nanosuspension formulation production. Applied Design of Experiment principles on Covaris acoustic nano-milling instrument to predict parameters needed to mill novel APIs. Developed HPLC methods for quantifying API concentration in formulations.

Responsible for inter-department drug formulation and documentation for dosing of animals and cell lines. Maintain a GLP Laboratory for formulation production. Took part in SOP and laboratory improvements to increase productivity and GLP compliance. Successfully passed a FDA audit. Develop and transfer HPLC methods for dose verification of formulation samples. Track schedules and billing information for bioanalytical projects in an effort to improve inter-department communication.

Tokyo, Jp, Jp

Performed non-GMP activities to support pilot scale purification runs for toxicology studies and experimental use. Formulated and produced 1 to 600 Liter batches of buffer solution in support of development timelines. Assisted purification team during capture operations, packing operations, and protein purification operations. Took part in experiments for pilot plant, including a leachables/extractables study and endotoxin testing for toxicology studies. Maintained a database of buffer results and statistically determined specifications for buffers. Produced quarterly and yearly reports of buffer data. Maintained inventory of consumables, chemicals, and documents.

Nashua, Nh, Us

Experimented with polyurethane adhesives to improve upon and develop products for customers. Tested a variety of properties of potential products including mechanical strength and bond testing. Configured and utilized a gas chromatograph instrument to identify solvents.

Tampa, Fl, Us

Tutored a student in math and science to improve grades. Prepped the student for the MCAS.

Wall Township, New Jersey, Us

Performed baseline groundwater sampling for homeowners and entered and maintained accurate records and data of sampling activities formatted to the client's direction. Compiled and finalized reports associated with samples.

Master'S Degree, Chemistry

Bachelor'S Degree, Chemistry

Education record