Process Development Engineer III — Biotech Scale-Up Transfer

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 90,000 - 141,000; Full time

Job summary

Takeda Lexington, MA is seeking a Process Development Engineer III to design, optimize, and scale-up cell culture manufacturing processes. You will collaborate with scientists, engineers, and manufacturing teams on technology transfer and development programs from early stage to commercialization.

You will execute experiments, analyze data, and author protocols while maintaining documentation and supporting cross-functional projects in a GMP environment.

Qualifications

• Associate’s degree with 4+ years, Bachelor’s degree with 2+ years, or Master’s degree with 0+ years of relevant industry experience in Chemistry, Biology, Pharmacy, Engineering, or a related scientific discipline.
• Experience in a biologics laboratory or GMP manufacturing environment.
• Experience maintaining and troubleshooting laboratory equipment.
• Ability to follow written procedures, SOPs, and work instructions.
• Experience documenting laboratory work using batch records or notebooks.
• Strong written and verbal communication skills.
• Ability to learn new techniques and manage multiple priorities.
• Knowledge of aseptic technique, solution chemistry, and lab equipment operation (bench-top bioreactors).
• Experience preparing cell culture media and process solutions.
• Preferred: experience supporting technology transfer.
• Cell culture process development experience in biopharma.
• Familiarity with scale-up and process optimization.
• Experience in a cross-functional development organization.

Responsibilities

• Execute process development experiments and unit operations with limited supervision.
• Prepare and author experimental protocols and supporting documentation.
• Contribute to project deliverables across development programs.
• Independently analyze, interpret, and communicate experimental data.
• Identify technical challenges and implement solutions with team collaboration.
• Support design and execution of new experiments and process improvements.
• Author and support technology transfer documentation for internal manufacturing and external partners.
• Collaborate cross-functionally with scientists, engineers, and manufacturing teams.
• Maintain laboratory facilities, equipment, and documentation per procedures.
• Present project updates and experimental results to teams and leadership.
• Apply biological and engineering principles to solve process development challenges.

Skills

Process development

Cell culture

GMP manufacturing

SOPs

Education

Bachelor’s degree

Associate’s degree

Master’s degree

Tools

Bench-top bioreactors

Job description

Takeda Lexington, MA is seeking a Process Development Engineer III to design, optimize, and scale-up cell culture manufacturing processes. You will collaborate with scientists, engineers, and manufacturing teams on technology transfer and development programs from early stage to commercialization.

You will execute experiments, analyze data, and author protocols while maintaining documentation and supporting cross-functional projects in a GMP environment.