Digital Capability Management , LIMS Systems
About the Job
Digital Quality Systems Lead will serve a key role managing the delivery of the Laboratory Information Management systems (LIMS) like Labware LIMS, Thermo Fisher Scientific Watson LIMS and other systems used in Pharmaceutical Development. This role is accountable for managing of LIMS system demand, implementation and evolution of strategic information systems that globally enable Pharmaceutical Development to streamline processes, particularly around data management and analysis. This role is within the Application Development & Support, Lab Systems IT department and will partner with Pharmaceutical Development, other internal IT service teams, outsourcing partners, and vendors to define, prioritize, plan, deliver and support strategic digital capabilities.
- Accountable for the controlled production support and lifecycle management for LIMS applications used by Pharmaceutical Development including Biologics development.
- Accountable for implementing digital capabilities that have the greatest impact on Pharmaceutical Development Analytical organizations , setting appropriate expectations, and ensure that IT delivery resources are appropriately engaged to deliver solutions. Contribute heavily towards developing a plan for development activities and translate those into actionable projects. This includes releases, required modifications and discretionary enhancements to support the application lifecycle.
- Ability to translate business requirements to technical documentation and artifacts. Must be able to wireframe and prototype solutions.
- Strong understanding of Software Development Lifecycle; experience with all phases of a SDLC.
- Ability to interact with users and translate needs into maintainable configurations, extensions and customizations.
- Ability to design, author, edit and execute test scripts.
- Ability to author SDLC documentation, including requirement, plans and summaries.
- Developing/supporting applications.
- Design, develop and test software as part of new product and maintenance development.
- Experience working with relational databases (Oracle preferred) and Crystal Report.
- 8+ years in information management leading teams and big projects.
- Knowledge of LabWare LIMS Architecture, Database, LIMS Basic Configuration and SQL queries.
- Experience in building interfaces to SAP and ELN to LIMS.
- Knowledge of cGXP and 21CFR Part11 standards and strong knowledge of laboratory and process operations in Pharmaceutical Development.
- Minimum 6 - 8 years of experience in .Net development with Oracle & SQL Databases.
- Experience in C#, ASP.NET, ADO.NET and MVC Architecture.
Strong working experience in Database Programming using RDBMS databases like Oracle & SQL Server.
- Experience in working with Crystal Reports using Visual Studio.
- Thorough knowledge of Object Oriented Programming concepts.
- Must be customer focused and team oriented, possessing good interpersonal, oral and written communications skills.
Ideal Candidates Would Also Have\:
- 3-5 years of experience utilizing Labware LIMS and a minimum of 2-3 years of Labware LIMS administrator experience.
- Demonstrated working understanding of cGMP and laboratory operations and practices.
- Strong communication skills (verbal and written).
- Demonstrated ability to work independently and collaboratively on cross-functional teams.
- Strong organizational and/or project management skills.
- Experience with Labware LIMS & Watson LIMS preferred.
- A minimum of 3 years of IT experience in application support and maintenance.
- BS in a relevant IT or scientific discipline with at least 3-5 years’ experience in Pharmaceutical Industry would be preferred.
- 5+ years’ experience in IT, roles involving business analyst, project management, data analytics, and/or informatics.