<p>Responsibilities</p> <ul> <li>Manage performance and professional development of staff </li><li>Oversight and leadership of multiple managers, departments, or sites as appropriate </li><li>Guide and make decisions on scientific, operational, and regulatory issues, as appropriate </li><li>Perform tasks on a site or global level </li><li>Implement programs and drive process improvement to assure financial and budget expectations are met </li><li>Establish department objectives </li><li>Track revenue and assist with financial planning and budgeting </li><li>Develop capabilities and resources to meet present and future needs </li><li>Develop and execute strategic plans to meet business growth objectives </li><li>Support Business Development in development of new and existing clients </li><li>Establish Key Performance Indicators to identify opportunities for improvement </li><li>Participate in client and regulatory audits as required </li><li>Implement programs and drive process improvement </li><li>Oversee staff recruitment, training, and progression </li><li>Ensure employee adherence to regulatory compliance for data integrity and assigned SOPs </li><li>Other tasks as assigned </li></ul> <p>Skills, Education & Qualifications</p> <ul> <li>Ph.D. degree in biology or related major, with 10+ years' of working experience in bioanalytical CROs or bioanalysis in a pharmaceutical or biotechnology company. </li><li>Strong scientific knowledge of bioanalysis of biomarker, ADA, Nab and PK using LBA technologies. Knowledge of PCR and flowcytometry technology is a plus </li><li>Strong knowledge and understanding of regulatory requirements; GLP, GDP, GCP, 21CFR Part 11. </li><li>Excellent knowledge and understanding of the pharmaceutical industry. </li><li>Extensive experience in managing/conducting studies to support projects. </li><li>Excellent communication skills (writing and speaking). </li><li>Extensive experience in ELN and LIMS. </li><li>Able to lead, mentor, inspire and develop scientific staff. Ability to set and lead strategy for growing a group. </li><li>Able to guide trouble shooting for problematic projects (method development, validation and sample analysis) with the team. </li><li>Able to develop and implement research strategies and align with organizational goals. </li><li>Able to foster scientific excellence and build scientific reputation internally and externally. </li><li>Ability to identify opportunities and respond quickly to client requests and expectations. </li></ul>