Nicholas Bohn Email & Phone Number

Manages and consults projects related to manufacture, quality, and regulation of pharmaceutical and nutritional products.Promotes community health by working with wrestling athletes and coaches to create and implement personalized training programs while also providing officiating services.Implements regenerative agricultural practices to improve nutritional yield while providing on-site education and accommodations.Identifies and engages clients while maintaining relevant education and certifications.

Developed and prepared CMC regulatory packages for global BLA submissions. Managed technical documents, timelines, and all regulatory-relevant communications. Responded to information requests from global regulatory bodies with quick turnaround through global collaboration and project management.This was a completed contract assignment with Astellas Pharmaceuticals through staffing agency Crystal Equation, LLC.

Tarrytown, New York, Us

As the CMC (chemistry, manufacturing, and controls) regulatory lead of multiple clinical drug candidates I coordinated with internal and external stakeholders to develop CMC regulatory strategies while adhering to strict timelines for IND/BLA submissions. Projects included the preparation, authoring, and submission of module 3 regulatory documents in eCTD format according to ICH guidelines.An impactful aspect of this position was responding to information requests from global regulatory bodies representing US, EU, and Rest of World.

Tarrytown, New York, Us

Managed a team of GMP-qualified personnel and their projects to drive biologics production according to ICH guidelines. Our team produced monoclonal antibodies according to global regulatory standards for patient use by performing cell culture in bioreactors and purification using column chromatography. Projects in this role included authoring CMC, Quality, and Manufacturing documents. As a GMP qualified trainer I have trained operators to perform drug production processes with their career advancement in mind.I continually optimized manufacturing and quality processes by tracking data patterns, identifying room for improvement, and then implementing controls to ensure our drug products were made in a safe and consistent manner. The most satisfying aspect of this role was working with my team to provide monoclonal antibodies for Covid-19 treatment under high levels of scrutiny and with quick turnaround.

Tarrytown, New York, Us

Los Angeles, Ca, Us

‘Improving Stem Cell Transplant Therapies with a Small Molecule Inhibitor of Mitochondrial Proteins’--> Keystone Symposia Cancer and Stem Cells Award Recipient (2016)--> CSU Northridge Outstanding Graduate Research Promise Award (2016)--> California Institute of Regenerative Medicine Bridges to Stem Cell Research Award (2015)Stem cell metabolism is a fascinating world - mitochondria play a crucial role in proper development of embryonic human cells. In this work we show that embryonic and induced pluripotent stem cells are more sensitive to a mitochondrial inhibitor than their specialized progeny. I developed more than 10 novel stem cell culture lines and characterized their behavior when treated with drug compounds.I enjoyed collaborating to design experiments that address multiple questions. Flow cytometry, western blot, and mitochondrial isolation were used to analyze the effects of a mitochondrial inhibitor on different stem cell populations. Understanding the processes underlying growth and specialization of stem cells not only improves the safety of stem cell transplant therapies but also provides unique insights into cancer cell development.

Marquette, Michigan, Us

Prepared and calibrated various solutions, instruments, and equipment for laboratories within the Biology department.Maintained records of inventory, ensuring equipment and material conditions exceeded compliance standards.Disposed of hazardous and corrosive waste products according to SOPs.

'Characterization of Apoptotic Genes within Tumor and T-cell Populations Grown in Low Oxygen'--> Upper Michigan Brain Tumor Center Research Fellowship (2014)--> Ronald E. McNair Postbaccalaureate Achievement Program (2013-2014)Research with UMBTC sparked interest in cancer biology; I learned to design experiments based on current literature, culture human tumor/immune cells, trouble-shoot molecular techniques, and present data.It was particularly exciting to establish a primary glioblastoma cell line from a real-time clinical patient through collaboration with the laboratory's neurosurgeon.Participation in poster and community outreach presentations connected lab research to the greater vision of improving human health.

Marquette, Michigan, Us

Enriched and supervised a community of 50 peers, fostering a safe living environment through connection, conflict resolution, documentation, and community engagement.

Master Of Science, Biology

Bachelor'S Degree, Biology, Human Physiology