Senior QC Analyst

Senior QC Analyst
Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and we’re always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.

We’re looking for an organized and focused self-starter to execute a series of analytical programs to support the quality control requirements for commercial pharmaceutical injectable products, including LIMS administration, sample receipt control, inventory and purchasing control.

Specifically, you will:

•Execute established analytical methods and generate the required data within set timelines
•Work in a strict cGMP compliant laboratory environment
•Maintain inventory of laboratory chemicals, reagents, standards and equipment
•Ensure compliance with SOPs and laboratory guidelines for the daily laboratory operation
•Record and archive equipment information regarding  maintenance, use and repair
•Conduct laboratory investigations for data in question
•Maintain inventory of samples prior and after testing and account for all sample reconciliation after the completion of studies
•Follow project timelines
•Deliver presentations for the work conducted or literature reviews requested by the management
•Generate technical reports and analytical summaries
•Maintain a training record per the cGMP requirements

This position requires:

•A BS/MS or equivalent experience in chemistry or related field with 4-6 years of experience in an appropriate industrial laboratory setup, OR an MS in chemistry or related field with 2-4 years of experience in a Pharmaceutical, Biotechnology or related laboratory setup
•Experience conducting all/some of the following quantitative analytical techniques: analytical assays for using HPLC, GC, IR, UV and fluorescence spectroscopy, density determination, titrimetric techniques such as Karl-Fisher titration for water content, viscosity measurement techniques, osmometry, polymer analysis, etc.
•Familiarity with a variety of biological cell based assay formats, such as reporter gene assays, cell proliferation assays and antibody neutralization assays
•Hands on experience with mammalian cell culture techniques and assay development and validation of cell-based bioassay procedures
•Excellent written/verbal communication skills
•The ability to work independently and proactively and to multi-task
•A team oriented attitude and problem solving abilities
•Experience with LIMS, Quality Assurance or Quality Control, method validation, method transfer, amino-acid analysis, peptide sequencing, and cGMP regulations is a plus.
•Knowledge of biopolymer testing and handling would be helpful.

By “Challenging Science,” Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases. Amylin’s approach and dedication are rooted in the belief that we will be “Changing Lives” for millions of people. At Amylin, you’ll have the chance to truly make a difference in people’s lives. We also recognize top talent when we see it, and we reward it, generously, through our competitive compensation & benefits program. Amylin is proud to be an equal opportunity employer.




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AMYLIN

Challenging Science. Changing Lives.