Michael Brooks Email & Phone Number

United States

Merrillville, Indiana

Cincinnati, Ohio

Group LeaderResearch & Technology Development

Cambrdge Isotope Laboratories, Andover, Ma

Responsibilities include development and technology transfer of drug substance manufacturing processes for Archemix drug development programs.Provide technical assistance and supervision for manufacturing activities at contract manufacturing organizations (CMOs), and performing technical review and/or authorship of batch records and technical reports.Responsible for the conduct and development of gram scale synthesis of oligonucleotides, preparative HPLC purification, and post-synthetic conjugation or purification processes.Responsible for technical evaluation of process changes, impact assessments and written documentation in support of such changes.Assist with the technical evaluation processes of contract manufacturing organizations (CMOs) and assist with troubleshooting issues related to product design with product development, process development and QA/Quality Control (QC).Participated in evaluation of raw materials or of critical components (PEG, linkers, etc…) for drug substances.

Custom Manufacturing of Oligonucleotides under cGMP and non-cGMP conditions.Extensive experience with Akta Oligopilot 100 Synthesizer, OligoPilot 400 Oligonucleotide Synthesizer, Akta 100 Purifier, Bioprocess 6mm SKID and the Uniflux Ultrafiltration/Diafiltration System. Trained on the NovaSep HiperSep Chromatography SystemSynthesized modified and unmodified DNA, RNA and si-RNA molecules for Toxilogical and Phase I & II clinical trials ranging from milligram to kilogram quantities under cGMP and non-cGMP conditions.Responsible for developing methods for the purification of modified and unmodified DNA, RNA and si-RNA molecules using anion ion exchange and reverse-phase HPLC methodologies.Developed methods for the desalting of the modified and unmodified DNA, RNA and si-RNA molecules using reverse-phase HPLC and/or HPUF using size-exclusion membrane technology.Responsible for writing new SOP and Work Instruction for new equipment acquisitions.

Phd, Organic Chemistry

Activities and Societies: Synthesized the food derived pro-carcinogens and pro-mutagens IQx and Trp-P-2 and their N-Acetoxy ester.

Ms, Chemistry

Activities and Societies: Performed research experiments to observe the chemical characteristics and interactions at the surface of black.

Hs

Education record