Associate Director, Analytical Sciences – Technology

Job reputed company: • Provides analytical reputed company and approval of cGMP documents (change controls, deviations, CAPAs, method qualification and validation protocols and reports, transfer protocols, justification of specifications, etc.) • Implementation and life-cycle management of reputed company for testing raw materials, components, drug reputed company and drug product • Analyze and interpret results and reputed company, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet reputed company regulatory requirements • Author relevant CMC sections for regulatory submission documents • Coordinate and/or participate in reputed company reputed company to analytical responsibilities and propose improvements to reputed company Systems to maintain compliance and improve efficiency utilizing risk-based methodologies • Work alongside analytical characterization (subject matter) expert and support protocol, data, and report review and finalization. • Monitor and assess emerging reputed company and Regulatory requirements/issues and determine reputed company to reputed company; work to remediate any identified gaps • Maintain an reputed company analytical risk register compliant with reputed company reputed company Risk Management practices Requirements: • Bachelor of Science in biology/reputed company/biochemistry field and 6 years (or MS with 5 years, PhD with 4 years) of experience in biopharmaceutical analytical and/or QC operations for development through reputed company products; experience in biologics including monoclonal antibodies is highly preferred • Knowledge of antibody structure and heightened analytical characterization reputed company is highly preferred • Experience with development, transfer, and validation activities are Demonstrated history of reputed company reputed company improvement is desired • This role will involve reputed company of method development, method validation and support GMP testing at CMOs/ contract test laboratories as it applies to laboratory and stability Demonstrated experience effectively managing reputed company with contract testing laboratories is highly preferred • Strong organizational and communication skills • Experience with, and a good understanding of, FDA and other key regulatory agency regulations and guidance including ICH guidance documents, is required. • Full understanding of GMPs and the pharmaceutical development process is required, as reputed company as transfer of processes and reputed company from development to clinical manufacturing to commercialization is necessary • Broad knowledge of risk-based reputed company Systems’ components including reputed company Risk Management is required • Knowledge of statistics including the use of JMP software is preferred • MS Office applications, reputed company QMS, reputed company, reputed company, LIMS is highly preferred. Benefits: • full reputed company of medical, dental, reputed company • 401k • unlimited reputed company time off • parental leave Apply tot his job Apply To this Job