Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. Ardea is seeking an Associate Director, Analytical Sciences to join it's dynamic team.
Associate Director will be responsible for managing stability and a significant part of outsourcing program for the Analytical Sciences function in a manner which complies with departmental and corporate SOPs, GLPs and cGMPs. This includes participation in departmental planning activities and managing multiple projects and operational areas.
He/she will be responsible for design, implementation and administration of stability studies for Ardea development projects through clinical development, registration filings and up to commercialization. Additionally, this person will be responsible for management and coordination of laboratory operations, such as instrumentation calibration, maintenance and qualification; analytical testing documentation; samples management and inventory.
Primary Duties and Responsibilities
• Lead and manage design and administration of Drug Product and API stability programs for contract laboratories/CMOs and for development studies within Ardea.
• Manage ICH registration stability programs for drug substances and drug products
• Participate in auditing and selecting contract service providers to conduct release and stability testing for development compounds and clinical supplies.
• Create and review financial and contractual terms with contract service providers as pertains to stability programs.
• Manage technical review and approval of stability data generated by Analytical Sciences group and by contract laboratories/CMOs.
• Ensure stability testing timepoints occurs according to predetermined and approved testing protocols
• Work with the reference materials administrator to ensure that materials are qualified for use. Review excursions and discrepancies and design stability strategy to support investigation of OOS and OOT results.
• Ensure adherence to stability guidelines and cGMP compliance.
• Author stability sections of regulatory submissions.
• Respond to CMC Requests for Information and address questions from regulatory agencies. Participate in PAI and GLP inspections, GMP audits, and due-diligence meetings.
• Work with CMOs to ensure that quality agreements and stability protocols are executed properly. Review and develop trending programs to monitor drug substance and drug product over time.
• Represent stability function in CMC teams and work cross-functionally with all other groups such as regulatory, product development, process chemistry, preclinical development.
• Serve as primary liaison with other departments, business partners and outside vendors on projects.
• Ensure that appropriate testing methods are transferred and validated for use in the stability programs.
• Develop, follow and enforce departmental and corporate procedures (SOPs).
• Draft departmental SOPs, stability protocols, reports, and other documents.
• Manage and develop procedures for the qualification and use of laboratory equipment.
• Manage and coordinate timely calibration, maintenance and qualification of laboratory instrumentation.
• Ensure the maintenance of instrumentation records and lab notebooks in a concise, legible and complete manner.
• Provide input for continual improvement of procedures, systems, areas, compliance with cGMPs, company procedures, FDA regulations and ICH guidelines.
• Provide training, guidance and leadership to new and less experienced staff.
• Maintain up-to-date knowledge of applicable industry and regulatory guidelines and requirements and disseminate this information to colleagues
• Carry out job responsibilities and assignments safely and maintain a clean and safe work area.
• Other duties as may be necessary.
BioSpace.com - 17 months ago