Senior Analyst - Quality Digital & Innovation (LIMS/MODA)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description 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. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. #GMSGQ #ZR1 #LI-MA1 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. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. 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.