GMP Production Technician

Cambridge Isotope Separations (CIS) has an outstanding opportunity for a GMP Production Technician based onsite in our Xenia, OH location. CIS is the world leader in the separation of 13C and 18O and is a subsidiary of Cambridge Isotope Laboratories (CIL) in Massachusetts, the world’s leading producer of stable isotopes and stable isotope-labeled compounds. CIL separates both 13C and 18O at its Xenia, Ohio, facility and has the world’s largest production capacity for both 13C and 18O. CIL also has the only large capacity nongovernmental D2O (Deuterium Oxide) enrichment columns in the world located at its CIS facility.

Our GMP Production Technicians work in a team-based environment and are responsible for safety, production, maintenance, and product quality. They are expected to understand and use automated control systems, production machinery, and laboratory equipment.  Ability to work unsupervised and a willingness to succeed is required. 

Responsibilities

• Work on the GMP production process for  13C Urea for Medical Diagnostics
• Disassemble, clean and reassemble production equipment to prepare for processing
• Consistently conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meet specified parameters following strict GMP procedures
• Operate process equipment to create product that meets predetermined specifications
• Transfer processed materials through production equipment to include mixers, vacuum pumps, filtration equipment, etc.
• Package finished product and transfer to warehouse
• Adhere to all cGMP guidelines
• Follow all documentation procedures assuring that paperwork is in accordance with all regulatory standards
• Committed to meeting customer demand
• Additional responsibilities as required

Requirements

• High school diploma or GED from an accredited institution
• Disciplined execution of work instructions, excellent organizational skills and strong interpersonal communication capabilities
• Two years of chemical/pharmaceutical production plant experience is preferred but not required
• GMP experience is preferred
• Ability to move/lift materials or equipment as needed up to 50 lbs

Benefits

CIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.

CIL is an EEO/Affirmative Action employer.

Learn more about us on our website: www.isotope.com

About Us:

Cambridge Isotope Laboratories, Inc. (CIL) is the world’s leading producer of stable isotopes and stable isotope-labeled compounds. With approximately 750 employees and laboratories in four countries, CIL specializes in the process of labeling biochemical and organic compounds with highly enriched, stable (nonradioactive) isotopes of carbon, hydrogen, nitrogen and oxygen. Our chemists substitute common atoms (e.g., 1H, 12C, 14N, 16O) with rare, highly valued isotopes (e.g., 2H or D, 13C, 15N, 18O) so that the final product can be readily measured or traced using mass spectrometry (MS) or nuclear magnetic resonance (NMR). CIL’s products are utilized in laboratories, medical, government and academic research centers and health care facilities worldwide.

We are proud that CIL products have contributed to medical advancements in cancer research, new-drug development, environmental analysis, and medical diagnostic research. In the past decade, as the fields of proteomics and metabolomics have developed as leading techniques for determining biomarkers for disease presence, progression and the monitoring of therapeutic response, CIL has worked closely with industry leaders and researchers to provide the stable isotope-labeled tools needed for improved quantitation and qualification of complex biological systems.

After decades of research, stable isotopes have found their place in an ever expanding commercial scale applications in pharmaceuticals, semiconductors, flat panel displays as well as other high technology fields specifically with deuterium oxide (D2O) and deuterium gases. Pharmaceutical companies have begun to investigate deuteration of molecules that may provide advantages over their existing nondeuterated counterparts. In addition, increasing research into the potential medical advantages of new deuterated drugs is also occurring. In high technology, deuterated organic molecules and deuterium gas are commonly used in the manufacturing of microelectronics and OLEDs, which contribute to the increased lifetime of the devices.

Learn more about us on our website: www.isotope.com