IT Program Manager - LIMS
Description
We are seeking an IT Program Manager that is experienced, agile, and collaborative and has maturity, confidence, strategic thinking, and sound judgment/decision making skills. The IT Program Manager will work closely with the Director of IT, Director of Quality Control, and QC LIMS Administrator to implement, support, enhance, and maintain compliance for the Laboratory Information Management System (LIMS) and all supporting Quality Control Laboratory instrumentation systems.
This position requires a passion for IT and systems development. Project management and business analyst experience is critical to the role. As well as the ability to work independently and in a team environment at all levels of the organization. The IT Program Manager will be influential in championing and developing IT initiatives, specifically regarding LIMS and QC Laboratory Systems. You will possess a demonstrated ability to influence positive outcomes without direct reporting authority.
Essential Job Functions:
- Provide oversight and direction for LIMS and QC Laboratory systems and drive solution delivery to meet systems development, validation, and management activities.
- Partner with the QC LIMS Administrator to implement best practices, develop training, and adoption of the LIMS system. The IT Program Manager will be the lead for the overall system design, system capabilities, and vendor management. The QC LIMS Administrator will be the lead for QC processes and master data development.
- Execute and lead multiple projects and technical work assignments as a point of contact for project stakeholders.
- Improve business processes and efficiency by proactively pursuing/building business cases and requirements for new and improved functionality.
- Partner with key stakeholders across the organization to execute program improvements and plans.
- Execute and update documentation for the support of LIMS and QC Laboratory systems to aid in system adoption by personnel and ensure assets are reliable, accessible, and secure.
- Provide administrative support and liaison with partners for assigned systems and supporting applications by completing tasks such as computer software assurance, periodic reviews, access reviews, and systems administration.
- Lead implementations and changes by discovery, defining, configuring, testing, and documenting integrated business processes.
- Coordinate and leverage internal and external resources for support and project implementations.
- Provide digital plant subject matter expertise (SME), to multi-function teams, advises stakeholders on application configurations, data integrity, cyber security, and defend work before regulatory agencies.
- Ensure alignment with directives and industry guidelines for applications.
Special Job Requirements:
- 5+ years of progressive Business Systems Analyst experience.
- 5+ years of experience managing LIMS, or QC Laboratory Instrumentation systems.
- 3+ years proven experience as a Program or Project Manager using project management tools and methodologies.
- Proven experience driving complex projects to completion highlighting the use of robust project management skills.
- Commanding knowledge of building SOPs, systems support, Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices to support working within a regulated environment.
- B.S. in Life Sciences, Engineering, Computer Science, or equivalent experience.
- Advanced Degree in Informatics a plus.
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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