BioSpectra, Inc.
Crystal Rose Hamelburg has a diverse work experience spanning multiple industries. Crystal Rose is currently working as the Director of Compliance at BioSpectra, Inc. since October 2022. Previously, they held roles such as Associate Director of Compliance, Compliance Manager, Regulatory Manager, Quality Assurance Manager, Quality Assurance Specialist, and QC Analyst III at the same company between 2014 and 2020.
Before joining BioSpectra, Inc., Crystal worked as an EMT at Pocono Mountain Regional EMS from January 2013 to June 2016. Crystal Rose also had a sales and marketing role at The Organic Warehouse from May 2009 to April 2014.
In 2008, Crystal worked as a lifeguard at Camelback Mountain Resort.
Crystal Rose Hamelburg has a diverse education history. Crystal Rose obtained a Master of Science (MS) degree in RA/QA from the Temple University School of Pharmacy, graduating between 2018 and 2022. Prior to that, they attended East Stroudsburg University of Pennsylvania from 2010 to 2014, where they earned a Bachelor's of Science Degree in Biotechnology. Additionally, they obtained a Bachelor's of Science Degree in Biology/Biological Science and a Minor in Chemistry from the same institution during the same time period. Before their time at East Stroudsburg University, Crystal Rose Hamelburg pursued an Associate's degree in Education from Northampton Community College from 2008 to 2010.
In terms of certifications, Crystal Rose Hamelburg holds an EMT-B certification from the Commonwealth of Pennsylvania. However, no specific information regarding when or where this certification was obtained is provided.
BioSpectra, Inc.
BioSpectra is a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including actives, excipients, GMP process chemicals, and bulk GMP buffers and solutions. Our focus is small molecule synthesis and true, phase-change multi-step purification for both traditional and biopharmaceutical applications. Our services include contract GMP product development, coupled with ongoing commercial manufacturing and regulatory support, up to and including DMF submissions. All of our manufacturing processes are fully validated. Our U.S.-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Onsite analytical testing capabilities include multi-compendial and custom specifications, with full traceability and transparency of all raw materials and sources. Our commitment to quality, compliance and true, U.S.-GMP manufacturing, testing, and regulatory support is unparalleled. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have. GMP Product Categories: • Bulk GMP biological buffers • Active & functional excipients • GMP process chemicals and bulk GMP Solutions Custom GMP Services: • Purification of key ingredients • Full GMP product development • Small molecule custom synthesis • API development and manufacturing • Custom GMP compounded solvents and solutions Comprehensive Quality and Regulatory Program: • FDA registered and inspected • Document support (DMF submissions) • Global GMP requirements (US, IPEC, ICH-Q7)