Job Title: Quality Digital & Innovation, Senior Analyst (LIMS/MODA)

Location: USA Mass Bio Ops, Massachusetts

About the role:

As a Quality Digital & Innovation, Senior Analyst (LIMS/MODA), you will support the administration, maintenance, configuration, and continuous improvement of laboratory systems supporting the Massachusetts Biologics Operations (MBO) site. You will work primarily with LabWare LIMS and MODA, maintaining workflows and master data, supporting system and instrument integrations, and providing first-tier application support to QC laboratory personnel. The role will also support computer systems validation activities, system documentation, and change management while ensuring laboratory systems remain compliant with applicable regulations and data integrity requirements. This position requires strong technical knowledge of LabWare LIMS, including experience with LabWare 8, as well as the ability to collaborate closely with QC, laboratory, manufacturing, IT, vendors, and global system stakeholders.

How you will contribute:

• Maintain and update workflows, master data, and configurations within LabWare LIMS and MODA to support routine business operations and continuous improvement.
• Assist with system and instrument integrations, including configuring interfaces between LIMS and QC laboratory instruments and coordinating with Technical System Owners and Global DD&T partners.
• Perform master data updates and resolve master data issues while supporting routine system administration activities.
• Provide first-tier application support to QC laboratory end users, including troubleshooting and resolving routine system and usage issues.
• Create and maintain method verification scripts, system documentation, and other technical documentation supporting new functionality and routine system updates.
• Support computer systems validation activities, including validation plans, user requirements, protocols, reports, and related documentation.
• Configure and maintain interfaces between laboratory systems and QC instruments, including experience with Modbus or similar communication protocols where applicable.
• Support change controls, system requests, and IT ticketing activities through systems such as ServiceNow while coordinating required communications and approvals.
• Partner with laboratory, QC, manufacturing, IT, vendors, and other stakeholders to identify opportunities for system and process improvements while maintaining the validated state and data integrity of laboratory systems.
• Support regulatory inspections and serve as a technical subject matter expert for applicable laboratory systems and processes.

What you bring to Takeda:

• Bachelor's degree in Engineering, Computer Science, Business, Chemistry, Biology, or a related discipline preferred; equivalent relevant work experience may be considered in lieu of a degree.
• 2-4 years of pharmaceutical or biopharmaceutical industry experience, preferably supporting laboratory systems or QC environments.
• Strong hands-on configuration and development experience with LabWare LIMS and/or MODA; experience with LabWare 8 is highly desirable.
• Experience with SQL or SQL-based configuration capabilities, particularly in support of LabWare LIMS.
• Experience developing or configuring interfaces between LIMS and QC laboratory instruments; experience with Modbus or similar communication protocols is desirable.
• Experience supporting computer systems validation, including validation plans, URS, protocols, reports, and related documentation.
• Working knowledge of cGxP, GAMP 5, ISA-88, 21 CFR Part 11, data integrity principles, and validated laboratory systems.
• Strong collaboration, communication, problem-solving, and organizational skills, with the ability to manage multiple workstreams and work effectively with laboratory, manufacturing, IT, vendors, and global stakeholders.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
USA - MA - Lexington - BIO OPS

U.S. Base Salary Range:
$89,900.00 - $141,240.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

Locations
USA - MA - Lexington - BIO OPS

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.