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Job Description

About the Role:

The Manufacturing Sciences (MS) Senior Data Science Engineer I is responsible for managing Continuous Process Verification (CPV) activities including routine evaluation, escalation of signals, cross-functional meetings, statistical analyses, and Product Quality Reviews (APQR, YBPR).  The role contributes to the technical management of GxP and non-GxP systems (e.g. Statistica, Spotfire, SIMCA) and ensures data integrity and usability through data stewardship and engineering solutions.  Key areas of accountability include modifying and maintaining Statistica workspaces (i.e. Statistica Administrator duties), managing control limits, and supporting Takeda’s digital Capabilities.  Have specific subject matter expertise in process of distributed control systems, PI historian, Statistica, Discoverant, LIMS, JMP and other multivariate process analytical tools. Expertise to identify potential improvement projects utilizing advanced analytics and process knowledge. Working in commercial manufacturing facility and GxP experience is preferred.  Previous project management implementing similar systems/programs at other biotech or biopharma companies is also required.  Strong cross collaboration skills are essential. Be a data steward, ensuring data integrity, visibility, and usability. Support data engineering solutions to automate GxP activities. May support Manufacturing investigations as a digital and statistical expert.

How you will contribute:

• Lead CPV program initiatives including APQR, PQR, YBPR, cross functional meetings.

• Perform statistical analyses

• Control limits and monitoring strategy evaluation

• Act as a subject matter expert (SME) for Statistical Process Control (SPC)

• Ensure data integrity, visibility, and usability through stewardship initiatives.

• Execute data science and data engineering solutions to automate GxP and non-GxP activities to enhance operational efficiency

• Drive and support transformative digital projects to advance Takeda’s digital culture and digital ways of working

• Statistica Administrator: Manage end users, develop automations, develop and maintain workspaces.

• Support MA BioOps end users for applicable dashboards Regulatory and RTQ data requests

• Statistical analysis support.

• Support regulatory inspections including routine GMP inspection

• Have expertise in multivariate modeling methods, including PCA/PLS. OPLS, Discriminant analysis, etc.   Support MA BioOps end users for applicable dashboards

• Work with SMEs to collect and process data for use in creating models, utilizing a variety of automated tools (e.g. VBA, R/Python)

• Individual will be able to assess and design a phased approach in the project plan based on readiness of peripheral systems, design and building of process models and capital/resource availability.

What you bring to Takeda:

• Bachelor’s degree in an engineering discipline, biological sciences or business (with a strong background in life sciences operations) with a minimum of 5 years of combined experience or Master’s degree with 3 years of experience in production environment utilizing GMP systems for supply chain (SAP or any other ERP) or manufacturing operations management such as MES (Manufacturing Execution Systems).

• Sound understanding of manufacturing operations and related functions, from Supply Chain planning to product release.

• Proficiency in managing systems and platforms (e.g. Statistica or other data science tools)

• Knowledge of SPC including statistical methods

• Proven ability to write maintainable code in programming languages (Python or R)

• GxP software validation; Data governance and stewardship

• Data mining, machine learning, statistical modeling

• Some experience with Large Language Models (LLM) in Pharmaceutical applications

• TIBCO Data Science / Statistica, TIBCO Spotfire, SIMCA, Discoverant, Databricks Qlik, Tableau, PowerBI, Power Automate, AWS, Big Data platforms

• Ability to interact well in multifunctional teams and with personnel at all levels in the organization

• Familiar with systems validation execution and related documentation

• Knowledge of statistics for process monitoring

• Strong written and verbal communication skills

• Proficient in the use of Microsoft Office

• Knowledge of GMP manufacturing processes

• Aptitude/interest in developing new insights for manufacturing operation management, and willingness to learn new technologies, standards and best practices.

• Good understanding of biopharmaceutical batch manufacturing, material flow, unit operations and scheduling/planning

• Ability to apply industry regulations and best practices to decision making process

• Commitment to sound methodologies and best practices

• Participate in problem resolution meetings/teams effectively

• Ability to shift priorities to meet required deadlines

• Effectively communicate issues cross-functionally and resolve them in a timely manner

• Trained on relevant industry regulations and cGMP compliance

• Excellent presentation skills

• Strong problem-solving skills and attention to detail.

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. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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.