As one of the largest biotechnology companies on the planet, Amgen offers the chance to truly innovate and contribute to the big picture in science. Our R&D; focus on nephrology, oncology, inflammation and bone disease, and neurology has already produced six marketed products with a promising pipeline of new human therapeutics to come. A world-class sales force, global manufacturing operations, and clinical development sites on three continents complete our picture as a Fortune 500 company and a leading biotechnology company committed to improving people's lives. And Amgen continues to grow with our successes. We currently have the following opportunity at our Thousand Oaks, CA facility.Laboratory Sytems Analyst II
Requirements:
BS or MS in Engineering, Information Systems Computer Science, or the Life Sciences, or equivalent combination of education and experience required. Typically 5 plus years related experience also required. Must be familiar with Software Development Methodologies for documenting and implementing validated systems. Must be familiar with 21 CFR Part 11 and 21 CFR Part 58. Demonstrate advanced project management skills, including, but not limited to the following: developing and reporting software project metrics, guiding a project from concept to delivery, project planning and scheduling, resource management/allocation, system validation, technical solution evaluation, and/or tracking budgets/schedules. Additionally, proven competence in project management, software development life cycle, and software quality methodologies.
Job Summary:
This position will manage various projects to implement and deploy scientific and data management systems for the Pharmacokinetics and Drug Metabolism (PKDM) Department. Provide support for IS software testing by participating in validations consistent with IS standards for Laboratory and Enterprise Systems. Identify and communicate gap assessments in handling data and in using software. Maintain PKDM systems and serve as the contact person for external IS-related initiatives, including software upgrades. Create and manage software-related SOPs and documents (URS, IQ/OQ/PQ) and training. Develop supporting documentation and monitor budgets, timelines and scheduled resources, and develop communication and coordination for projects that impact PKDM. Strong customer relationship skills required. Extensive knowledge of IT infrastructure, laboratory applications and their integral support role to the business is preferred. Must possess excellent leadership and interpersonal skills, strong verbal and written communication skills, and ability to facilitate cross-functional and cross-organizational coordination. Problem resolution and team building skills are required. Amgen outstanding compensation package features comprehensive benefits and relocation assistance.
Amgen outstanding compensation package features comprehensive benefits and relocation assistance. Come be a part of the big picture at Amgen.
Interested candidates please email resume to [email protected]
As an EEO/AA employer, Amgen values a diverse combination of perspectives and cultures. M/F/D/V
Laboratory Systems Analyst II openings at Amgen
Posted - 11/09/2005 : 3:58:35 PM
