LIMS Developer III

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The LIMS Developer III is responsible for incorporating laboratory subject matter expertise and software development subject matter expertise, the Laboratory Information Management System (LIMS) Developer III at Cook MyoSite, Inc. is responsible for software design, software development, and interface integration of MyoSite LIMS applications.

• Deliver features for the MyoSite COTS LabWare LIMS by
Primarily programming (i.e., LIMS Basic, HTML/CSS, and SQL) to extend the capabilities of the application.
Secondarily programming (i.e., C# and PowerShell) to provide integration and web service capabilities related to the application.
Provide software deployment activities for custom software, SQL procedures, COTS application, and host systems to support feature deployment from test - environments to validation, and then through to production.
Provide configuration of LabWare LIMS application workflows to define specific COTS application behavior.
• Independently operate as the site LIMS application subject matter expert (SME) for LabWare LIM
• Author design, functional, and integration specification documents for LabWare LIMS.
• Develop formal documented software unit tests as part of commissioning LabWare LIMS and/or LabWare LIMS related applications or integrations.
• Lead LabWare LIMS application demonstrations to ensure that end-user requirements are incorporated as expected in features.
• Adhere to Standard Operating Procedures (SOPs) and documentation requirements while providing the delivery of features for the LabWare LIMS.
• Communicate cross-functionally and with external consultants.
• Review and/or delegate work to technical professionals as needed.
• Provide 3rd level of support for custom software related issues to manufacturing or laboratory operations as needed, including off-hours.

• Exemplifies Cook MyoSite Core Values
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• Trainability
• Able to prioritize and operate proactively
• Must demonstrate critical thinking and proven problem-solving skills
• Strong interpersonal skills resulting in exceptional rapport with people.
• Proven success in initiating, promoting, and maintaining strong interpersonal relations.
• Must be able to multitask
• Demonstratable ability to work in collaborative and independent work situations and environments while multitasking.
• Demonstratable effective verbal, written and interpersonal skills.
• Demonstratable ability to prioritize and operate proactively with minimal need of supervision.

Undergraduate degree in Engineering, Computer Science, Information Systems, or 5+ years direct, relevant experience in LIMS Development to provide a comparable background.

Minimum of 5+ years' experience in LabWare LIMS programming (i.e., LIMS Basic, HTML/CSS, and SQL including Visual Workflows and ELN integration) along with software configuration and application

Proficient knowledge of Microsoft Office software, and other general office equipment.
Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing deployment.
Minimum of 2+ years of programming experience in PowerShell along with either C# or Python.
Minimum of 5+ years of experience in a LIMS related role providing value for manufacturing or laboratory operations.
LabWare LIMS Certifications: LabWare Configuration Using LIMS Basic, Visual Workflows, Reporting, SQC Charting, and Instrument Integration.

Full Time On Site

Physical Requirements:

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.

Employee that does not interact with Healthcare Professionals
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.
This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.