Engineer III

Role Summary

Engineer III at Takeda Development Center Americas, Inc. located in Lexington, MA. The role involves independently carrying out bioreactor operations across scales (250 ml to 10 L), preparing experimental protocols, supporting tech transfer of developed cell culture processes to pilot and manufacturing facilities, and contributing to technical reports and cross-functional project teams. Up to 20% remote work is allowed.

Responsibilities

• Independently carry out bioreactor operations across scales (250 ml to 10 L).
• Prepare experimental protocols and support tech transfer of developed cell culture processes to pilot team and manufacturing facility.
• Design experiments, interpret data, identify complex technical issues, and implement solutions under supervision.
• Contribute to technical reports by writing and consolidating technical documents.
• Interact with process development, optimization, characterization, troubleshooting, and large-scale studies to support project goals.
• Support technology transfer through writing and consolidating technical documents, reviewing batch records, and coordinating cross-functional projects.
• Evaluate new technology/equipment applicable across multiple programs.
• Document data accurately per company guidelines; draft technical reports, memos, procedures, protocols, and presentations; provide organizational support and participate in cross-functional project teams; present at department and project meetings.
• Execute bioreactor operations, clarifications, and purification using high-throughput systems such as ambr250 and Tecan.

Qualifications

• Required: Master’s degree in Chemistry, Biology, Pharmacy, Engineering, or related Pharmaceutical Science.
• Required: Prior experience executing bioreactor operations, primary clarification, and purification using high-throughput systems (e.g., ambr250, Tecan); design experiments to assess and optimize process performance.
• Required: Ability to independently interpret experimental data, identify complex technical issues, and implement solutions under supervision; contribute to evaluation and integration of new technologies across programs.
• Required: Collaboration with cross-functional teams to support tech transfer of processes to Pilot, Manufacturing, and external CDMOs; ensure seamless integration of new processes and technologies.
• Required: Author and revise technical documents, including SOPs and process development reports; provide cross-training on analytical instruments and techniques.
• Required: Conduct product quality testing using tools such as Solo-VPE, Lunatic, HPLC, UPLC, and UV spectrophotometer.

Skills

• Bioreactor operations
• Process development and tech transfer
• Experimental design and data interpretation
• Technical writing and documentation
• Cross-functional collaboration
• Analytical instrumentation (HPLC, UPLC, UV, Solo-VPE, Lunatic)

Education

• Master’s degree in Chemistry, Biology, Pharmacy, Engineering, or related Pharmaceutical Science