Position:Business Systems Analyst (LIMS)
Location:Boston, MA (Hybrid - 3 days onsite)
Length:12+ months
Job Description:
Our client is seeking an experienced and dedicated Business Systems Analyst to join a dynamic team. The successful candidate will play a crucial role in supporting the Laboratory Information Management System (LIMS) for cell and gene therapy operations. This position offers the opportunity to work in a collaborative, cross-functional environment, helping streamline critical business processes related to data management and system integration.
Essential Duties and Responsibilities (but not limited to):
- Collaborate with site leaders to capture, update, and maintain master data within LIMS for various operations, including Quality Control (QC), Quality Assurance (QA), Supply Chain, Manufacturing (MFG), and analytical groups at multiple sites.
- Support the implementation, enhancement, and review of processes related to master data creation, revision, and approval across GxP and non-GxP environments.
- Provide first-line support for end-user issues related to LIMS templates, data entry, and system usage.
- Assist with the development and implementation of site-specific processes for scheduling and tracking the status of all LIMS master data, ensuring compliance with operational requirements such as Raw Materials, Drug Substance, Finished Product, and stability testing.
- Partner with LIMS Administrators and Business Owners to ensure adherence to both local and global LIMS requirements.
- Participate in the development or revision of Standard Operating Procedures (SOPs) for the LIMS system.
- Support LIMS system and process audits to ensure that data is current and meets regulatory standards.
- Assist in the integration of non-GxP digital platforms, such as Benchling and Dotmatics, to support various life sciences programs.
- Coordinate end-user training sessions and supporting the business in gathering digital platform business requirements, use cases, and user stories.
- Act as a superuser for digital platforms and working closely with subject-matter experts to identify and fulfill business needs.
- Train junior specialists on system knowledge and troubleshooting technical difficulties in collaboration with the technical team.
Qualifications:
- Advanced degree in technology, science, or a related discipline, or equivalent experience (background in biology, data analysis, statistics, or data science is preferred).
- 2-4 years of relevant experience in life sciences or an equivalent combination of education and experience.
- Familiarity with cell and gene therapy methodologies, such as cell viability, flow cytometry, and functional assays.
- At least 1 year of experience working with LabVantage LIMS, with a strong understanding of system functionality and master data management.
- Experience with Benchling and Dotmatics systems, with a general understanding of their functions and system navigation.
- Knowledge of instrument data capture systems and regulated systems, including systems validation processes.
- Strong multitasking skills and the ability to manage multiple concurrent projects.
- Experience working with GxP laboratory and manufacturing processes, as well as non-GxP research and product development processes.
- Detail-oriented with strong attention to minute details.
- Excellent verbal and written communication skills.
- Ability to work effectively in a team environment, taking on additional or new responsibilities as needed.
- Experience in working with both GxP and non-GxP environments, with a focus on regulatory compliance is strongly preferred.
- A proactive, solutions-oriented approach to problem-solving and system enhancements is preferred.
- Experience with training and mentoring junior team members in systems and processes is a plus.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
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Digital Prospectors
Mar 06, 2025 