Oversees the key, core assay development groups within Analytical Development. Responsible for overseeing new method development, assay qualifications and validations, as well as internal and external assay transfers. Partners with Testing Operations management to transfer methods from Analytical Development to Testing Operations. Provides high-level technical support as needed. Manages assay functional leads and supervisors and is responsible for strategical
planning, project timelines, appropriate resourcing, setting appropriate goals, and personnel development. Possesses rigorous scientific skills in biologics testing and a strong working knowledge of Good Manufacturing Practice (cGMP) compliance requirements for biologics testing. Remains current regarding regulatory testing requirements and
develops / modifies assays in accordance. Remains current in the scientific areas of their respective functional areas and serves as a key subject matter expert to the organization. Engages clients and auditors regularly.
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
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