Principal Associate, Analytical Development
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POST DATE 8/31/2016
END DATE 11/18/2016
San Diego, CA
JOB DESCRIPTIONThe Principal Associate position will focus on developing, qualifying, and validating new methods in support of PaxVax vaccine development programs. The candidate will also perform release and stability testing of pipeline candidates through all phases of product development. Experience working in a GMP laboratory environment, as well as a detailed knowledge of analytical requirements for parenteral and oral products is required. Experience with biomolecular methods, including cell-based, immunological, and molecular biological assays, as well as standard laboratory techniques (Karl Fisher, pH determination, spectroscopic methods etc.) is also required.
Develop, qualify, validate, and transfer biomolecular test methods for testing drug substance and drug product with guidance from management
Perform in-process, release, and stability testing following approved standard operating procedures (SOPs) and test methods
Interact with external contract service providers to direct and/or facilitate method development and product testing in support of PaxVax projects
Write and review protocols, reports, test methods, and SOPs
Maintain accurate and complete laboratory notebooks, logs/logbooks, and records following GXP documentation practices
Conduct and document investigations following SOPs and GXP guidelines; initiate and close deviations, CAPAs, and change requests
Follow SOPs and laboratory guidelines for daily operation of GXP laboratories
Author and review analytical data summaries to support batch release and stability assessments for clinical materials
Assist in maintaining inventories of chemicals, reagents, and reference materials
Perform routine maintenance and calibration of laboratory equipment and instrumentation
Qualify and/or validate analytical instruments and equipment
Maintain training record per GXP and company training requirements
Develop presentations to communicate information to internal groups and management