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Cambridge Isotope Laboratories, Inc. (CIL) has an excellent opportunity to join our Quality Control RP/ISO Laboratory team as a Quality Control (QC) Group Leader based onsite in our Andover, MA location. 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 QC 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, Operations and Logistics group and ISO 17025 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 guidelines and GLP best practices
• Calibrate and maintain laboratory equipment
• Evaluate data and solve QC related problems
• Supervise daily laboratory activities
• Review 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

• Bachelors degree in Chemistry and 5+ years of analytical laboratory experience or a Masters or Ph.D. degree in Chemistry and 3+ years analytical laboratory experience
• A minimum of 2 years as a team lead or supervisor of other chemists required; team lead or supervisory experience in a QC lab preferred
• GMP/ISO QC experience preferred
• Familiarity with testing in a GMP or ISO environment is required
• Hands-on experience with LIMS/LES/CDS systems strongly preferred
• Ability to handle multiple tasks, take initiative and follow through required
• 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

Benefits

CIL offers a competitive salary and a comprehensive benefit program including generous paid time off, health insurance with no in-network deductibles, multiple Long Term Incentives and 6% matching 401K plan.

CIL is an EEO/Affirmative Action employer.

Learn more about us on our website: (link removed)

About us:

Cambridge Isotope Laboratories, Inc. (CIL) is the worlds leading producer of stable isotopes and stable isotope-labeled compounds. With over 700 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). CILs 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: (link removed)