Senior Manager - LIMS

About Us

Headquartered in Princeton, New Jersey, USA, with offices in Canada, India, and Germany, we are a leading publicly traded global SaaS company that helps enterprise life sciences organizations accelerate new drug development into approved medicines that save lives and keep employees safe. Through our intelligently designed low-code software platforms, we digitize drug research and development, laboratory testing, regulatory approvals, and pharmaceutical manufacturing on a single, unified cloud platform that is cost-effective, ready to deploy, and easy to use.

Highly regulated companies choose Xybion to help them become more efficient, reduce costs and manage compliance, regulatory adherence and risk. Since our founding in 1977, we have supported through software, services, and consulting, 100% of the top 20 global life sciences companies.

Serving more than 160 customers in 25 countries, we have the global scale and expertise to bring our employees around the world together to drive innovation, manage complex business processes, improve program administration and client service delivery.

Senior Manager LIMS:

The Senior Manager, LIMS Software Development is responsible for leading the design, development, and implementation of our Laboratory Information Management System (LIMS) software solutions. This individual will also be responsible for promoting our LIMS products through demonstrations and sales activities. Close collaboration with laboratory personnel, IT staff, business stakeholders, and customers is critical to ensure our LIMS software effectively supports laboratory operations, meets regulatory requirements, and aligns with market needs.

Job Location: Pune / Chennai

Responsibilities:

• Oversee the day-to-day operations of the LIMS software development team, including system design, development, maintenance, upgrades, troubleshooting, and user support.
• Develop and implement strategic plans for the LIMS software, ensuring alignment with the organization's overall strategy and business objectives.
• Gather requirements for LIMS enhancements and new features through customer interaction, market research, and stakeholder engagement.
• Lead the design, development, testing, and implementation of LIMS enhancements and new features, ensuring they meet customer requirements and adhere to quality standards.
• Ensure the LIMS software meets all regulatory compliance requirements, including but not limited to FDA, CLIA, HIPAA, and GDPR.
• Coordinate and provide product demonstrations to potential clients, clearly explaining features and benefits of the LIMS software.
• Participate in sales activities, contributing to the development of proposals and negotiation of contracts.
• Develop and deliver training programs to customers and staff, ensuring proficient use and understanding of the LIMS software capabilities.
• Manage relationships with vendors, when necessary, to ensure the delivery of high-quality services and products related to LIMS software development.
• Oversee the LIMS software development budget, including forecasting, planning, and controlling costs.
• Prepare and deliver reports on LIMS software development operations, initiatives, and sales to senior leadership and other stakeholders.

Qualifications:

• Bachelor’s degree in information technology, Computer Science, or related field. Master's degree preferred.
• Minimum of 10 years of experience in LIMS software development, with at least 5 years in a management role.
• Hands on knowledge in Laboratory Information Management System (LabWare) with respect to Pharmaceutical and Manufacturing domain.
• Good knowledge on LabWare LIMS v6 and v7 along with ELN.
• Good knowledge in Managing LIMS Tables, Folder Manager, Static Data Creation and Modification, Sample Login Templates, Product, Analysis and Users configuration etc.
• Good knowledge in LIMS modules.
• Experience in Labware LabVantage migration, should be aware of migration methodology and execution Wide knowledgeable of FDA, GMP and GLP related regulations.
• Knowledge in configuration, customization, (Status Rules, Icon Rules, Info Rules, Event Triggers, User Programs, User Dialogs) and deployment of LabVantage LIMS
• Configuring Sample Plan, Item Code, Analysis and Product according to the specification documents received from customers for different product types like Raw Material, Drug Substance and In Process etc.
• Manage Administrative activities to create and modify LIMS user accounts, assigning new roles, role modification to provide reliable service to all the users.
• Handling of Laboratory Investigations and CAPA via TrackWise system.
• Work with vendors and other support teams to prioritize, escalate as necessary, and resolve identified technical issues and problems.
• Communicate issues and status to internal user community.

Compensation:

We offer highly competitive compensation, including a performance-linked bonus, along with a comprehensive benefits package.

We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/.