Sr. Scientist/Scientist, Analytical Sciences
Ardea Biosciences, Inc. - San Diego, CA

This job posting is no longer available on BioSpace.com. Find similar jobs: Senior Scientist Scientist jobs - Ardea Biosciences jobs

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 a Sr. Scientist/Scientist, Analytical Sciences to join its dynamic team.

We are seeking a Senior Scientist/Scientist, Analytical Sciences who will carry out the responsibilities of the Analytical Sciences function in a manner which complies with departmental and corporate SOPs, GLPs and cGMPs. He/she will be responsible for analytical activities for an assigned project (projects) to support pre-clinical lead candidate through clinical development registration filings and up to commercialization. This may include participation in departmental planning activities and providing leadership for an assigned project or functional area.

Responsibilities include:
  • Coordinate, design and perform laboratory studies with minimal guidance. May plan and coordinate laboratory activities of other staff members. Laboratory studies include the analytical testing of development compounds and formulations; dosing analysis studies to support GLP toxicology and preclinical PK studies; preformulation and stability studies; reference standard characterization; methods development and validation for raw materials, intermediates, drug substances and drug products.
  • Perform analytical testing with high proficiency utilizing HPLC, LC/MS, GC, dissolution, UV and FTIR, and other analytical techniques; demonstrate the ability to operate, maintain and trouble-shoot equipment.
  • Develop and validate test methods for drug substances, intermediates and drug products.
  • Summarize experimental findings, perform data calculations, interpret and document study results, assemble analytical data packages.
  • Provide training, guidance and leadership to new and less experienced staff.
  • Supervise and direct other employees as appropriate.
  • Prepare development reports and assist in the preparation of regulatory submissions.
  • Present work at departmental and interdepartmental meetings as appropriate.
  • Maintain up-to-date knowledge of applicable industry and regulatory guidelines and requirements and disseminate this information to colleagues.
  • Coordinate outsourcing activities as appropriate.
  • Draft departmental SOPs, test methods, and other documents; provide input for their continual improvements.
  • May serve as liaison with other departments, and outside vendors on projects.
  • Identify equipment and technology needs, recommend and purchase equipment.
  • Follow departmental and corporate procedures (SOPs).
  • Follow current GLP and GMP regulations.
  • Maintain research records and lab notebooks in a concise, legible and complete manner.
  • Identify systems and areas in need of improvement and coordinate subsequent corrective activities.
  • Carry out job responsibilities and assignments safely and maintain a clean and safe work area.

BioSpace.com - 15 months ago - save job - copy to clipboard - block