Sr Associate Research Operations

Thousand Oaks, CA 91320

Posted: 05/17/2016 Employment Type: Contract Industry: Research Job Number: 1598

Job Description:
The successful candidate will perform routine testing, method development and qualification using biophysical methods to support product and process characterization activities for protein biopharmaceutical products. Activities will include the characterizing of higher order structure and aggregation attributes in drug substance and drug product, as well as characterizing product stability during storage. The methods currently used in the laboratory includes analytical ultracentrifugation (AUC), size exclusion multi-angle fight scattering (SEC-MALS), field-flow fractionation (FFF), and differential scanning calorimetry (DSC). The biophysical methods will be applied to drug substance and drug product comparability studies, characterization of product degradation pathways, and non-routine investigations. Other duties include performing complex data analyses, generation of technical documents and technical presentations, and setting of acceptance criteria in support of process development, process/method transfers, and comparability studies. The position requires demonstrated ability to work collaboratively with other scientists. 

Top 3 Must Have Skill Sets: 

Experience with biophysical methods, good documentation skills, able to work independent

Basic Qualifications: 
• M.S degree in Chemistry, Biochemistry, Biotechnology, Physics or related discipline, OR 
• B.S. degree in Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Physics or related discipline with 3+ years work experience in the biopharmaceutical industry 
Preferred Qualifications 
• Two or more years of experience directly related to biophysical characterization in protein drug products 
• Strong laboratory analytical skills, including routine testing as well as the design and execution of scientific experiments and interpretation of results 
• Experience developing, qualifying, and/or validating analytical methods, analyzing data, and setting acceptance criteria to support product comparability studies 
• Demonstrated ability to work collaboratively with other scientists on multidisciplinary, cross-functional teams
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