Senior Application Engineer, Quality Management System: Lead Developer/Analyst

Gilead Sciences

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Location: Foster City, CA Posted Date: 4/15/2013 Position Type: Full time Job Code: 12111 Required Education: Bachelors Degree

Description

The Lead Developer/Analyst serves as the primary point of contact for the Pharmaceutical Manufacturing Development (PDM) Informatics organization with various stakeholders in the clinical and commercial segments of Gilead Quality Assurance organization to standardize the usage of custom-built Pharmaceutical Quality System (PQS) across Gilead.
In addition, the Lead Developer/Analyst is responsible for project planning, development, scope and objective, progress, time frame, and deliverable(s).
Specific responsibilities
- Adapt to existing work environment and learn new concepts quickly
- Self-motivated, detail oriented, and a team player with the ability to effectively mentor team members during the course of developing high-quality applications
- Analyze problems, identify solutions and alternatives, and implement solutions and recommendations
- Research, analyze, and evaluate new methods, procedures, techniques, equipment, and provide clear and concise reports
Required skills
- Strong understanding of Object Oriented design and development with experience in building n-tier applications with service oriented architectures
- Hands-on experience with Agile and Test Driven methodologies and their SDLC
- Experience with Pharmaceutical industry is highly desirable
- Experience with current Good Manufacturing Practices (CGMPs), Food and Drug Administration (FDA), and other regulatory requirements preferred
- Good written, verbal, and interpersonal communication skills

Essential Duties and Job Functions:

- Design, develop, and maintain an enterprise system to provide seamless solution for clinical and commercial segments of Gilead QA in the following areas: Interactions with Commercial Manufacturing Organizations (CMOs) - Creating, reviewing, and approving materials and lots for use in Gilead products
- Develop and maintain internal- or external-facing enterprise-grade, distributable, scalable, high-quality, and high-performance web applications, on the Microsoft technology stack
- Develop scalable products with strong ties to other Gilead systems Integrate web applications with other Gilead applications through Oracle enterprise middleware
- Develop, execute, and document Unit and Integration tests
- Build and/or enhance systems to fulfill customer requests for additional functionality and enhancements to in-house-developed applications
- Develop functional requirements documentation, specifications, technical design documentation, and/or other related technical documents
- Assist validation team with troubleshooting and deviation resolution
- Work cross-functionally (IT Technical Architecture and Enterprise Systems group) to guide system development projects, from concept to deployment, and to improve PQS usage across Gilead
- Work with business owners to gather system requirements and scope, develop project plan, and monitor and communicate project progress throughout software development lifecycle

Requirements

- BS or higher degree in computer science, information systems, or other related filed
- 8 or more years of hands-on experience with web application technologies including but not limited to C#, .NET Framework, ASP.NET (front-ends and SQL Server back-ends), SQL Server, T-SQL, Hibernate, Crystal Reports, Visual Studio 2005+, Telerik Controls, and HTML5
- 2 or more years of hands-on experience in designing UI Frameworks in HTML5/CSS3, JSON, jQuery, and JavaScript
- Experience with Object Relational Mapping (ORM) tools, Visual Studio integrated prototyping tools and version control systems

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