Sr. Scientist/Scientist, Analytical Sciences

Organization: 
Ardea Biosciences/AstraZeneca
Job Location: 
San Diego, CA 92121
Job Description: 

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.

Requirements: 

• MS + 5 years, or BS +10 or more years experience.
• Practical experience in scientific discipline.
• Ability to design, conduct and interpret laboratory studies with minimal guidance.
• Preferred experience with solid dosage forms testing.
• Ability to gain new skills with minimal guidance.
• Significant technical skills and hands-on experience with variety of analytical laboratory techniques (HPLC, LC/MS, dissolution, GC test methods, etc.).
• Experience and understanding of GLP and cGMP regulations.
• Significant analytical method development and method validation experience.
• The performance attributes that will be assessed are job knowledge/professional competency, initiative/contribution, teamwork, verbal and written communication, adaptability to change, quality of work, attention to detail, productivity, time management/organization and problem solving skills.
Apply online at: www.ardeabio.com/careers

Contact Information: 

Apply online at: www.ardeabio.com/careers

About Our Organization: 

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.