For Current Gilead Employees and Contractors:
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R & D Information Systems Manager - ELN
This position is in the Laboratory Information Systems (LIS) department within the Pharmaceutical Development & Manufacturing (“PDM”) organization. The System Manager is responsible for the BIOVIA Workbook (ELN) system including the configuration, documentation, and processes surrounding the use of the system in PDM laboratories. The System Manager leads a small team to help deploy, maintain, and enhance the system capabilities and/or upgrades.
- Work with Gilead’s Pharmaceutical Development and Manufacturing (PDM) group to implement a comprehensive laboratory informatics strategic plan for the enterprise. Identify the optimum combination of applications that meet the requirements of disparate laboratory and business functions.
- Serve as the System Manager for BIOVIA Workbook (ELN) product responsible for the software solution including configuration, documentation, and processes surrounding the use of system in PDM laboratories.
- Develop short-term and long-term product roadmaps aligned with business goals and PDM technology governance.
- Lead a small team to help implement, maintain, and enhance the system capabilities and/or upgrades.
- Perform design/code/build reviews to ensure software code and configurations meet standards.
- Help in project deliverables to meet client requirements, expectations and timelines.
- Provide system administration and technical support in a GMP regulated environment.
- Coordinate with cross-functional stakeholders such as IT Infrastructure teams, QA, Business Process Owners, Software vendor etc.
- Contribute to the support and maintenance of validation package in compliance with validation/documentation procedures as required by Gilead's methodology: URS, FRS, SDS, TM, and report specifications.
- Contribute to the support and maintenance of operational documentation including SOPs, Work Instructions, manuals, and training materials for end users and system administrators.
- Assist with critical data support and data analysis requests from internal stakeholders.
- Monitor system infrastructure health and performance regularly to ensure continuous system availability for 24x7 operational sites.
- Remediate security vulnerabilities on time to mitigate any security risks associated with the system software or server infrastructure.
- Work directly with customers to probe and ask effective questions to fully diagnose both the root cause of a problem and the customer’s comfort level with technology.
- Help to defend GXP systems audits as they relate to the above listed systems.
- Communicate pertinent system information to site/project leadership as needed.
Knowledge, Experience & Skills:
- A Bachelor’s Degree in Computer Science, Chemistry, Biochemistry or related discipline with a minimum of seven (7) years of experience, OR a Master’s Degree in Computer Science, Chemistry, Biochemistry or related discipline with a minimum of four (4) years of experience.
- A minimum of five (5) years of ELN and Lab Information Systems experience in the pharmaceutical industry.
- Strong ELN Business analysis and development skills.
- Experience using IronPython, Pipeline Pilot, C# .Net, and BIOVIA Workbook SDK to configure and customize ELN.
- Experience with providing leadership, direction and guidance to direct report supervisors and department employees and preparing and administering budgets.
- Understanding of the regulatory requirements in pharmaceutical development and manufacturing area.
- Experience in implementing LIMS technology road-map under a defined corporate methodology.
- Experience with managing an enterprise LIMS Implementation and global roll-outs in a Pharmaceutical environment.
- Prior experience implementing an ELN, LIMS, SDMS or CDS in large enterprise.
- Good working knowledge of laboratory testing processes, identification and implementation of laboratory automation projects.
- Experience in helping across all aspects of Software Development Life Cycle (SDLC) and Validation Life-cycle (VLC) methodology.
- Experience defending computer system validation package in front of auditors (external/internal).
- Project management experience.
- Knowledge of quality management systems such as TrackWise, ComplianceWire, Veeva Vault.
- Knowledge of systems server architecture and networking including tools such as Citrix XenApp, VMWare vSphere, and Big-ip F5 Load balancer.
- Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), and other regulatory requirements or policies
- Ability to work in a fast-paced environment.
- Exceptional interpersonal skills, including teamwork, coordination, facilitation, and negotiation.
- Strong leadership, communication and presentation skills.
- Excellent analytical, problem-solving and technical skills.
- Detailed oriented, systematic and rapid learner.
- Excellent planning and organizational skills.
- Exceptional written and verbal communication skills.
- Ability to communicate effectively with technical and non-technical audience.
Preferred Knowledge, Experience and Skills:
- Experience using PowerShell, Windows Message Queue, PL/SQL for systems administration.
- Experience in a Quality Control laboratory environment.
- PMP certificate.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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For Current Gilead Employees and
Please log onto your Internal Career Site to apply for this job.