Overview
General position summary:

The Business System Specialist Senior will be responsible for the creation and revision, as well as review and approval of LIMS master data within the LabVantage Laboratory Information Management System (LIMS) implemented at the company’s Cell and Gene Therapy sites (3 sites - all in the same area) for the GxP LIMS system.

This position will be responsible for providing end-user support for EMUM(Enviromental Monitoring / Utilty Monitoring) , program as well as compliance with global Our compny’s internal policies and procedures.

The Sr. specialist is also responsible for stakeholder management, across functional lead.

The Sr. specialist is responsible for supporting the CGT site processes from LIMS perspective.

The Sr. Specialist will drive the LIMS master data including EMUM (Enviromental Monitoring / Utilty Monitoring) process from the very beginning to the end including change control management, master data verification, data migration etc..

Onsite Requirement: 5 days/week at site (no remote option).
Work Hours: Flexible; some team members begin as early as 5–6 AM. Must be available during core window (e.g., 9–4 PM).
Contract Length: 6 months (with possible extension due to project timelines or delays).

Experience & Skill Preferences

Strong working knowledge of MUMAPSAPQ processes.
Experience in XP process manufacturing, MOM, and QC lab workflows.
Must be detail-oriented, able to manage accurate and compliant data in GxP systems.
Ability to build and manage specifications in a pharmaceutical manufacturing setting.
Experience working across QA, QC, DT, and other cross-functional teams.
Effective communication and ability to collaborate across functions.
Ideal candidates will have relevant pharma/biotech experience, preferably with LIMS/LabVantage and regulated EMUM processes.

Ideal Candidate Attributes per the Manager:

Candidates must already possess relevant domain knowledge; limited ramp-up time available.
Should require minimal training on core systems but can be trained on our company's specific processes.
Ability to work well across teams and adapt to business protocol quickly.
Flexibility and strong stakeholder collaboration skills are essential.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

· Work with site leaders to identify, capture and update all master data for each site within our client company for GxP operations.

*** Work with a project team to identify, capture and update all EMUM , ,master data for the operations within Cell and Gene therapy site.

· Leads QC, QA and MFG departments in the build and/or revision, review, demo and approval of LIMS master data, including but not limited to products, sampling plan, specifications, methods, sample points, and LES templates in LIMS, per global and local LIMS procedures.

·First-line support for end-user LIMS LES templates and data entry issues, COA generation, EMUM data module etc.

· Support in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing master data for CGT at MC site facilities.

· Assist in the development and implementation of a site process for the scheduling and status tracking of all sites LIMS EMUM Master Data.

· Work with the site LIMS Administrator and Business Owner to maintain site and global requirements of LIMS.

· Participate in the development and/or revision of our Standard Operating Procedures.

· Corporate with training for end users to use the system.

· Collect digital platform business requirements, user story and use cases, support user acceptance testing as needed.

· Act as digital platform superuser and coordinate with business subject-matter experts from different levels for business needs.

· Responsible for training Jr. specialist with system knowledge and drive through technical difficulty in partnering with the technical lead.

· Responsible to master data module maintenance and perform system master data related impact assessment and taking change actions.

· Build instruments and consumable including critical reagents master data in LIMS system.

Minimum qualifications:

· Bachelor's degree in technology discipline or equivalent in technology or science discipline or equivalent. Combined degrees and/or experience in fields of biology, data analysis, Statistics and data science is preferred.

· Typically requires 2- 4 years relevant experience in the Life Sciences, or the equivalent combination of education and experience.

· Knowledge of LabVantage master data and system usage functionality, requires at least 3 years’ experience.

· Familiarity with Environment monitoring and Utility monitoring program within a GxP pharmaceutical manufacturing environment.

· Knowledge of regulated systems – general level of understanding of systems validation.

· Capable and comfortable multi-tasking between concurrent projects.

· Experience of GxP laboratory and Manufacturing process, and non-GxP research laboratory analytical development and product processes development.

· Must demonstrate ability to work in a team environment and willingness to assume additional or new responsibilities readily.

· Must detail oriented pay close attention and notice minor details.

· Effective communication skills, both verbal and written. Knowledge of regulated systems – general level of understanding of systems validation.

· Skills of Master Data management in LabVantage LIMS Systems, together with Data Analysis/Data Management.

· Capable and comfortable multi-tasking between concurrent projects.

Job Types: Full-time, Contract, Temporary

Pay: $110,000.00 - $120,000.00 per year

Benefits:

Green card sponsorship
Visa sponsorship

Application Question(s):

Do you have 3+ years of LIMS Labvantage experience in the pharmaceutical / Life Sciences?

Experience:

(Enviromental Monitoring / Utilty Monitoring) : 3 years (Required)

Work Location: Hybrid remote in Boston, MA 02210

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