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Quality Control Group Leader

Company: Cambridge Isotope Laboratories, Inc.
Location: Andover
Posted on: November 26, 2022

Job Description:

Cambridge Isotope Laboratories has an outstanding opportunity to join our Quality Control RP/ISO Laboratory team as a Quality Control (QC) Group Leader based onsite in our Andover, MA location. The QC Group Leader will act as a project manager for method development and validation activities as well as 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 projects, being the primary point of contact for the department manager and external departments regarding the status of projects, and responding to procedural and technical questions from QC Analysts. The incumbent may also perform, develop, and validate 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, new products team, and ISO 17034 reference materials program.
As the leading company in a niche scientific market, CIL works with cutting edge researchers in clinical diagnostics, metabolic research, proteomics, environmental testing, protein discovery, drug development, metabolomics, and industrial research. CIL's growing customer base spans academia, pharmaceutical and industry, 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 40 years.

* Schedule and perform method development projects in some of the following: GC, HPLC, NMR, LC/MS, and/or wet chemistry projects
* Follow GMP guidelines and GLP best practices
* Calibrate and maintain laboratory equipment
* Evaluate data and solve QC related problems
* Manage projects within the group
* Review data
* Perform method development, validation, troubleshooting
* 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


* Bachelor's 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; LC/MS experience a plus
* 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 ELN/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

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

Learn more about us on our website:

About us:
Cambridge Isotope Laboratories, Inc. (CIL) is the world's leading producer of stable isotopes and stable isotope-labeled compounds. With nearly 600 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:

Job Type: Full-time%58047475%

Keywords: Cambridge Isotope Laboratories, Inc., Boston , Quality Control Group Leader, Other , Andover, Massachusetts

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