Senior Laboratory Informatics Professional

Company Summary:

Kriya is a next generation gene therapy company focused on expanding the field to new frontiers. We have built a fully integrated, technology enabled platform for rational vector design, analytical characterization, and scalable manufacturing to design and develop gene therapies for diseases with well-understood underlying biology. We believe that rationally engineered gene therapies can transform the treatment of a broad universe of diseases – and we are prepared to lead this revolution in medicine.

Our team is made up of leading scientific experts who are passionate about improving patients’ lives and easing the burden of these life-changing disorders for patients. We are looking for teammates with the ambition, creativity, and energy to help us build a unique organization.

If you are looking to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, Kriya is the company for you.

Position Summary:

We are seeking a highly motivated, experienced, and professionally agile individual contributor to join the Operations Technology team at Kriya. This individual will serve as the principal lead for managing the storage of data in laboratory information management systems (LIMS), electronic notebooks (ELN), and other data platforms within the Kriya laboratories. In addition, this tactical position will serve as the system administrator for these systems and ensure the system maintains appropriate level validation and GxP compliance. Success in this role will require a strong ability to adapt to a fast-paced business and streamline implementations to support a growing company.

Primary Responsibilities:

• Champion and influence the design, build, validation, and implementation of informatics systems used within Kriya laboratories
• Champion and educate the business with good working knowledge of lab informatics systems, data science/statistical approaches such as data models, and lean processes
• Engage and communicate with multiple business functions and influence leadership on matters related to lab informatics systems
• Define, document, and analyze business processes based on LEAN principles
• Configure and maintain lab informatics systems based on user requirements
• Support incident management for of lab informatics systems
• Develop and configure lab informatics systems reports for laboratory processes
• Contribute to the support and maintenance of validation package for of lab informatics systems in compliance with Kriya validation program
• Develop operational and training documentation to support of lab informatics systems
• Track license costs, storage costs, development costs, and metrics as needed for of lab informatics systems

• Manage the day-to-day relationship with the of lab informatics system vendors to ensure compliance with all elements of the Master Service Agreement (MSA).
• Work with the vendors to deliver solutions to changing and new business needs
• Provided end-user system support including troubleshooting and resolution; make decisions that best resolve system related issues and appropriately escalate issues that require vendors and/or business management involvement

Required Qualifications:

• 
  Bachelor’s degree in Life Science field; Advanced degree preferred with additional education and training in computerized systems or equivalent knowledge and experience
• Minimum of 5 years of experience in cGMP and pharmaceuticals/biopharmaceuticals
• Strong familiarity with FDA regulations including 21 CFR Part 11 and GxP and international equivalents

• 
  5 years’ experience in laboratory informatics (eg LIMS, ELN or similar)
  • Experience with Benchling is desired, but not required
• Demonstrated ability to work with and manage software vendors, particularly SaaS vendors
• Demonstrated effectiveness in providing cross-functional leadership and delivering complex cross-functional projects
• Demonstrated proficiency with project management methodologies
• Proficiency in Microsoft office as well MS Visio and similar

• Excellent oral and written communication skills.
• Excellent interpersonal and organizational skills with strong attention to detail
• Good customer/client relationship management and proactive problem-solving skills.

Working Conditions:

• Work is normally performed in a typical interior/office or laboratory work environment
• Occasional weekend/off-hours work may be required

Kriya is an equal opportunity employer.

We celebrate diversity and are committed to creating an inclusive environment for all employees.

All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities and requirements of the position. Employees may be required to perform other job-related assignments as requested.