Engineer III, Upstream Pilot Lab

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Job Description

OBJECTIVE:

The Pilot Lab, positioned within the Research & Development (R&D) organization, serves as the critical interface between lab-scale development and full-scale manufacturing, and is Takeda’s only dedicated biologics pilot facility. This role is integral to the execution of large-scale upstream lab work (50-1000L) and experimental studies, contributing to the advancement of Takeda’s therapeutic pipeline. The successful candidate will support non-GMP batch production for cell expansion, culture, and clarification.  They will evaluate new technologies and processes, as well as assist in manufacturing investigations or process improvements. As part of the R&D digital transformation, the candidate will also participate in efforts to advance our data management and analysis.

The individual will independently execute both routine and complex operations, participate in planning unit operations/experiments, draft support documentation (SOPs, batch records, and/or reports), and analyze data (Spotfire or similar). They will apply knowledge from various technical areas, industry practices, and standards, and will provide quality and productive output that is consistently timely, reliable, and reproducible. The candidate should possess experience and knowledge of activities routinely performed in upstream (e.g. vial thaw, cell culture expansion, large scale bioreactor setup and control, centrifugation/depth filtration, and media/buffer preparation). Previous experience with single-use systems and DeltaV/OSIsoft PI software or other data management systems is preferred. Knowledge of downstream purification processing is a plus. This role is predominantly lab-based and will interact closely with counterparts in Process Development and Manufacturing Sciences.

This role offers a unique opportunity to apply cutting-edge science to bridge innovative research and large-scale production, supporting the delivery of next-generation therapies.

ACCOUNTABILITIES:

80% - Pilot-Scale Cell Culture Campaigns:

• Execute non-GMP cell culture operations at pilot scale (50-1000L) to support new product development, material supply, process improvements, and demonstration runs for various programs across the whole development lifecycle, including post-launch commercial processes.

• Partner with other process development and manufacturing sciences teams to troubleshoot and resolve process challenges and support large-scale studies.

• Coordinate and manage critical process details, including long-lead item tracking, sample planning, material ordering, and vendor interactions.

• Independently record, analyze, and interpret process data, identifying patterns and trends.

• Present findings and technical issues at departmental and project meetings, proposing solutions and implementing corrective actions under supervision.

• Contribute to pilot-scale procedures and documentation.

• Support global tech transfers.

• Support the authoring of technical reports, protocols, and internal presentations. Assist team members with scientific publications, external abstracts, and conference presentations as required.

20% - Technology and Digital Innovation:

• Evaluate and integrate novel pilot-scale technologies and digital tools to establish a versatile platform supporting multiple bioprocesses.

• Support the evaluation and implementation of PAT technologies (e.g., Raman)

• Drive continuous improvement through the adoption of innovative solutions to enhance efficiency, data analytics, and operational performance.

Education and Experience:

• Associate’s degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 4+ years relevant industry experience

• Bachelor’s degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 2+ years relevant industry experience

• Master’s degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant industry experience

• Previous hands-on experience working with bioreactors/fermenters at any scale, including process monitoring and process control.

Physical Requirements:

• Ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes.

• Ability to lift, pull, or push equipment requiring up to 25 lbs of force.

• Ability to stand for 4 hours in a suite.

• Ability to climb ladders or work platforms, or to stoop or bend to check or troubleshoot equipment.

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:

U.S. Base Salary Range:

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.

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Job Exempt