Quality Control Group Leader - RP/ISO Laboratory

Cambridge Isotope Laboratories, Inc. (CIL) is searching for aQuality Control Group Leader within the Research Products/ISO department based onsite in our Andover, MA facility. CIL is the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets. CIL's growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years.

The Quality Control Group Leader will oversee the daily work of the RP/ISO QC analysts and Senior QC analysts directly. This includes, but is not limited to: Scheduling and prioritization of routine samples and work assignments, review of data folders, performance of routine equipment maintenance, being the primary point of contact for the department manager and external departments regarding the status of daily work flow and responding to procedural and routine technical questions from QC Analysts. The incumbent may also perform and develop various analytical methods to determine isotopic enrichment, chemical purity, concentration, and identity testing on a wide array of stable isotope-labeled materials 13C, 15N, Deuterium, and 18O isotopes), in support of our production chemists, Supply Chain group, and ISO 17034 reference materials program.

Responsibilities

• Schedule, perform, direct/guide, and train others in some of the following:
• GC, HPLC, NMR, LC/MS, and/or wet chemistry techniques
• Follow GMP/ISO guidelines and GLP best practices
• Maintain laboratory equipment
• Evaluate and solve QC related problems
• Supervise daily laboratory activities
• Review associated data
• Author new documents such as testing methods, protocols, summary reports
• Perform QC-related investigations (OOS and CAPA) when applicable
• Provide performance-review input on lab staff

Requirements

• Bachelor's degree in Chemistry or a related concentration, with 5+ years of analytical laboratory experience
• Master's or Ph.D. degree in Chemistry or a related concentration, with 3+ years of analytical laboratory experience
• GMP/ISO QC experience preferred
• Ability to handle multiple tasks, take initiative, follow through required
• Prior experiences as a team lead or supervisor of other chemists required; team lead or supervisory experience in a QC lab preferred
• Demonstrated ability to follow documented standard operating procedures
• Demonstrated ability/experience to develop and troubleshoot analytical methods
• Demonstrated ability/experience of performing analytical investigations and implementing appropriate corrective actions
• Demonstrated ability/experience in preparing written reports
• Must possess strong verbal and written communication skills
• Must be able to work effectively independently and as part of a team
• Hands-on experience with LIMS/LES/CDS systems strongly preferred

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 ofstable isotopesand 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

Qualification

Bachelor's Degree