Process Development Engineer III Upstream

3316 Takeda Development Center Americas•Lexington, MA
•Onsite

About The Position

As a Process Development Engineer III, you will work primarily with scientists and engineers in the process development team to design, optimize, and scale-up cell culture manufacturing processes. You will support process development activities, technology transfer to internal manufacturing sites and CMOs, and contribute to technology innovation initiatives. You will independently execute routine and complex laboratory experiments, support process characterization and scale-up activities, analyze data, and contribute to technical documentation. Through collaboration with cross-functional teams, you will help advance process development programs from early-stage development through technology transfer and commercialization.

Requirements

  • 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.
  • Previous experience in a biologics laboratory or GMP manufacturing environment.
  • Experience maintaining and troubleshooting laboratory equipment.
  • Demonstrated ability to follow written procedures, SOPs, and work instructions.
  • Experience documenting laboratory work using batch records, laboratory notebooks, or other controlled documentation systems.
  • Strong written and verbal communication skills.
  • Ability to learn new techniques and manage multiple priorities effectively.
  • Knowledge of aseptic technique, solution chemistry, and laboratory equipment operation, including bench-top bioreactors.
  • Experience preparing cell culture media and process solutions.

Nice To Haves

  • Experience supporting technology transfer activities.
  • Cell culture process development experience in a biopharmaceutical environment.
  • Familiarity with scale-up and process optimization activities.
  • Experience working 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 significantly to project deliverables across one or more development programs.
  • Independently analyze, interpret, and communicate experimental data.
  • Identify technical challenges related to cell culture process development and implement solutions in collaboration with team members.
  • Support the design and execution of new experiments, applications, and process improvements.
  • Author and support technology transfer documentation for internal manufacturing and external partners.
  • Collaborate cross-functionally with scientists, engineers, manufacturing teams, and other stakeholders.
  • Maintain laboratory facilities, equipment, and documentation in accordance with applicable procedures and quality requirements.
  • Present project updates, technical challenges, and experimental results to team and departmental audiences.
  • Apply fundamental biological and engineering principles to solve practical process development challenges.

Benefits

  • equitable pay
  • pay transparency
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