Laboratory Systems (AMLN-02261)

Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic diseases through the discovery, development, and commercialization of innovative, cost-effective medicines. Our rapid growth has created the following outstanding opportunity in Cincinnati, OH:

 

Laboratory Systems

(AMLN-02261)

This position is responsible for working with the Amylin business departments and Amylin IT on the implementation and support of all laboratory instrumentation systems at the Amylin Ohio, LLC Manufacturing facility. This is an individual contributor role that will act as the central point of contact for all laboratory instrumentation systems. Focus will be on local system administration and support for GMP and non-GMP laboratory systems employed in the labs for data acquisition, analysis, monitoring and reporting (e.g., LIMS, StatLIA, Waters Empower, NuGenesis, Calibration Manager and others). This position will be based in Ohio, but will require 50-75% travel in the first 2 years to ensure close collaboration with Amylin San Diego project teams, including substantial training in San Diego.

 

The candidate must interface closely with Product Development, Quality, Validation, and IT departments in Ohio and San Diego. The candidate must also interface with external contract facilities and new/existing system users.

 

Responsibilities:Provide instrumentation end-user support and external supplier coordination for Amylin Ohio Labs.Participate in IT development projects to facilitate maintenance, upgrade and release of Lab systems.Facilitate communication with customers and to all levels of Amylin staff/management.Oversee work performed by local service providers/suppliers to ensure performance according to standards.Manage the inventory of laboratory equipment at Amylin Ohio. Implement systems under appropriate GxP controls for instrument and software qualification and validation via interfacing with Validation and Quality Assurance departments. Coordinate with Facilities and Engineering to assist with the planning of instrumentation installations and moves, including facilities requirements for power, weight, room size, network connectivity, etc. Work with the IT Operations department and the Laboratory Informatics group in San Diego to ensure proper laboratory server and workstation configuration, builds, qualification, implementation and change control. Recommend standards for instrumentation and software and assist other Amylin laboratories with the evaluation, selection and purchase of new instrumentation. Review all instrumentation purchases to ensure Amylin capitalizes on economies of scale (by buying standardized equipment that has been validated, etc.).Ensure that instrumentation systems have backup/restore and disaster recovery plans in place and manage the periodic testing of these procedures. Coordinate information flow among the members of various project teams, and between Amylin Ohio, LLC and Amylin San Diego. Work with suppliers, developers and Amylin staff to define and document business processes and system specifications. Develop user and system administration documentation and train users, as applicable. Support appropriate maintenance schedule and validation of instruments and upgrades, as needed. Serve as a technical resource for direct suppliers, consultants and in-house technical staff, as required.

 

Requirements:BS or equivalent experience, preferably chemistry or computer system technologies. 5+ years experience working in the pharmaceutical industry laboratory environment, preferably supporting pharmaceutical manufacturing (GMP experience preferred). Thorough knowledge of computers, laboratory instrumentation, and networking technology. NuGenesis experience a plus. Crystal Reports experience a plus. Experience in Oracle database management or client/server technology is also beneficial. Project management experience desirable.Working knowledge of Laboratory Information Management Systems (LIMS), Waters Empower, Structured Query Language (SQL), and Visual Basic programming language, would be desirable. A customer service orientation and excellent verbal/written communications skills. Ability to be flexible and proven high performer in a fast-paced team environment. Ability to work overtime and weekends, as needed.

 

Amylin offers competitive compensation, benefits and stock options. Amylin maintains a drug and alcohol free workplace and all offers of employment are contingent upon satisfactory completion of a pre-employment drug and alcohol test. Please apply online at: http://careers.amylin.com AA/EEO Employer.

 

Amylin

Pharmaceuticals