Associate Director/Director, Analytical Sciences
Ardea Biosciences, Inc. - San Diego, CA

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Ardea Biosciences, Inc., a San Diego based biotechnology company, is searching for an Associate Director/Director, Analytical Sciences to join the team. This is a new position due to company growth and will report to the Sr. Director, Analytical Sciences. It†s an exciting time at Ardea, as there is a gout product moving to Phase 3.

To apply to this position please visit: www.ardeabio.com/careersAssociate Director/Director will be responsible for a significant part of analytical development, stability, lab operations and outsourcing program (with a main focus on the drug product) for Ardea development projects supporting clinical development and NDA registration filing up to commercialization. He/she will conduct, coordinate and manage Analytical Sciences function in a manner which complies with departmental and corporate SOPs, GLPs and cGMPs. This includes participation in departmental management and planning activities and providing leadership for multiple projects or functional areas. Additionally, this person will be responsible for management and coordination of in-house laboratory operations, such as analytical testing coordination; instrumentation calibration, maintenance and qualification; documentation management; samples management.

Primary Duties and Responsibilities • Manage development, validation and technical transfer of various analytical methods supporting clinical development and NDA submission to the CMO and contract testing.• Manage ICH stability program for drug substance and drug product including registration stability. • Identify, manage and coordinate outsourcing activities.• Oversee internal and external analytical testing including HPLC, dissolution, spectroscopy, compendia methods; demonstrate the ability to manage the analytical testing function.• Plan and coordinate laboratory studies, plan and coordinate the activities of other staff members. This includes the stability testing of development compounds and formulations, methods transfer and validation activities, formulation development support.• Summarize experimental findings, review and interpret study results. Prepare and review development reports.

, • Draft and review CMC sections of regulatory submissions to support INDs, NDA and European filing. • Respond to CMC Requests for Information and address questions from regulatory agencies. Participate in PAI and GLP inspections, GMP audits, and due-diligence meetings. • Provide training, guidance and leadership to new and less experienced staff.• Supervise and direct other employees as appropriate.• Represent department and present work at departmental and interdepartmental meetings.• Maintain up-to-date knowledge of applicable industry and regulatory guidelines and requirements and disseminate this information to colleagues.• Serve as primary liaison with other departments, business partners and outside vendors on projects.• Develop, follow and enforce GLP and GMP regulations.• Implements SOPs and guidelines to ensure consistent practices for method validation and stability studies, as well as compliance with cGMPs, company procedures, FDA guidances, and ICH guidelines.

  • Develop, implement and enforce departmental and corporate SOPs, test methods, guidelines and other documents.• Provide input for continual improvement of procedures, systems, areas, compliance with cGMPs, company procedures, FDA regulations and ICH guidelines.• Identify equipment and technology needs, recommend and purchase equipment.• Develop procedures for the qualification and use of laboratory equipment.• Ensure the maintenance of research records and lab notebooks in a concise, legible and complete manner.• Carry out job responsibilities and assignments safely and maintain a clean and safe work area.• Other duties as may be necessary.

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