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R & D Info Systems Manager Laboratory Execution System (LES)
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Position Number: 2027429
Location: Foster City, CA
Position Type: Computer and Information Technology

R & D Info Systems Manager Laboratory Execution System (LES)
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

R & D Info Systems Manager - Laboratory Execution System (LES)

Specific Responsibilities:

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 Laboratory Execution System (LES) system including the configuration, documentation, and processes surrounding the use of the system in PDM laboratories and manufacturing operations. The System Manager leads a small team to help deploy, maintain, and enhance the system capabilities and/or upgrades.

Essential Functions:

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 LIMS, IM, and SmartLab products, collectively referred to as Laboratory Execution System (LES), 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 & Skills

Experience using Pipeline Pilot, BIOVIA LIMS and IM workflow SDK to configure and customize BIOVIA LIMS and IM solutions.
Experience PL/SQL for data retrieval and data analysis is preferred.
Experience with Providing leadership, direction and guidance to direct report supervisors and department employees and preparing and administering budgets.
Experience in Quality Control laboratory environment preferred.
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.
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).
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.

Education & Experience

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 with a minimum of four (4) years of experience.
A minimum of five (5) years of ELN, LES, LIMS or Lab Information Systems experience in the pharmaceutical industry.
Understanding of the regulatory requirements in pharmaceutical development and manufacturing area.
Strong ELN, LES, LIMS Business analysis and development skills.

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

About 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.

For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:
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