Senior Scientist, Analytical Development
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POST DATE 8/31/2016
END DATE 11/24/2016
San Diego, CA
JOB DESCRIPTIONThe Senior Scientist position will assume a leadership role focused on supporting Analytical Development and company pipeline objectives. The candidate will actively design, carry out, and evaluate analytical activities to advance preclinical/clinical stage novel vaccines through development, regulatory submission and approval, as well as supervise a team of scientists engaged is method development and GMP testing activities. Assure timely, appropriate method development, validation and implementation to meet project target profiles and ICH, USP, FDA, and EMA standards through a combination of internal and contracted activities. Vaccine projects will include a broad range of methods for characterization and quality control requiring strong competencies in cell-based and molecular techniques, both compendial and novel, applied to in-process materials, drug substance, and drug product. The Candidate must be able to effectively communicate results and issues to management and customers, internal and external, with excellent professional standards.
Develop, qualify, validate, and transfer analytical test methods for testing in process materials, drug substance, and drug product
Perform GMP release and stability testing of pipeline products
Supervise internal scientists engaged in developing analytical methods and performing release and stability testing of pipeline products
Interact with contract service providers to facilitate analytical development and testing activities
Author and review development reports and method validation protocols and reports
Author and review test methods and SOPs
Follow SOPs and laboratory guidelines for daily laboratory operations and functions, and develop continuous improvements
Conduct and document analytical investigations following SOPs and company requirements
Maintain accurate and complete laboratory notebooks and records following GMP and good documentation practices
Author and review analytical data summaries to support batch release and stability assessments for clinical materials
Generate analytical data and reports needed for the CMC sections of INDs, NDAs and other regulatory filings
Perform maintenance and calibration of laboratory instruments and equipment
Maintain training record per GMP requirements