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Position:
Senior Scientist/Project Manager- GxP Division
Employer:
Integrated Analytical Solutions, Inc.
Description:
Integrated Analytical Solutions, Inc. (IAS) is a GxP-compliant contract research organization (CRO) specializing in bioanalytical, analytical, stability testing and drug metabolism services for the biopharmaceutical industry. Our laboratories and offices are located in Berkeley, CA . Our company culture is built on the principles of teamwork, customer satisfaction and scientific integrity. We currently have a full-time opening for a Senior Scientist in our GxP Division. The selected candidate will be expected to manage client projects, supervise and perform laboratory activities, and support GxP compliance management.
Major Responsibilities:
- Perform duties as a principal investigator or study director including managing client deliverables and communication.
- Ability to efficiently operate in a regulated environment, including following SOPs and FDA regulations (GLP, GCP and cGMP).
- Prepare, review and approve protocols, test methods and reports.
- Review, interpret and reduce laboratory data.
- Contribute to developing and managing timelines and the allocation of resources for both client projects and the quality system.
- Work closely with colleagues for the development, validation and implementation of test methods based on LC-MS/MS, HPLC-UV, ELISA, SDS PAGE and other analytical chemistry techniques.
Qualifications/Experience:
- At least 10 years of industrial experience working in biopharma and/or a CRO. Title commensurate with experience.
- Extensive experience in bioanalytical methodologies using LC-MS/MS and/or analytical methodologies using HPLC.
- Experience working in a GLP, GCP or cGMP laboratory setting with a strong working knowledge of the GLP or cGMP regulations and related guidance documents.
- Experience in writing and reviewing SOPs and contributing to quality system functions.
- Client and project management experience will be given special consideration. Must have strong writing, editing, data reduction and overall computer skills.
- Desire to work in a close-knit, rapidly-paced environment that focuses on productivity and efficiency, and strives to maximize each employee’s contribution.
Location:
Berkeley, CA
Contact:
jonah@ianalytical.net
Post Date:
5/10/2016 3:03:50 PM
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