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Staff Engineer, Cell Culture Process Development

Takeda

Lexington, MAOnsitePosted 12 days ago$116,000.00 - $182,270.00
Full TimeSenior LevelManufacturing & CMCPharmaceutical
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Summary

The Staff Engineer, Process Development will play a key role in advancing BPD's platform development roadmap through technology-driven upstream process development. This position combines hands-on cell culture process development with data-driven approaches to enhance process understanding, performance, and scalability. The successful candidate will leverage expertise in cell culture, media development, cellular metabolism, and process analytics while collaborating closely with upstream program support teams and modeling experts to deliver innovative solutions for biotherapeutic development.

Job description

About the Role

The Staff Engineer, Process Development will play a key role in advancing BPD's platform development roadmap through technology-driven upstream process development. This position combines hands-on cell culture process development with data-driven approaches to enhance process understanding, performance, and scalability. The successful candidate will leverage expertise in cell culture, media development, cellular metabolism, and process analytics while collaborating closely with upstream program support teams and modeling experts to deliver innovative solutions for biotherapeutic development.

This role is ideal for a scientifically curious and collaborative professional who is passionate about integrating emerging technologies, advanced analytics, and systems-level thinking into next-generation cell culture platform development.

Key Responsibilities

  • Independently design, execute, and interpret cell culture process development experiments.
  • Generate and communicate data-driven conclusions and technical recommendations.
  • Author study plans, technical reports, presentations, and development documentation.
  • Lead and contribute to cross-functional project teams and global initiatives.
  • Collaborate with program support teams and modeling experts to deliver project objectives.
  • Serve as a technical resource, mentor, and trainer for colleagues.
  • Evaluate and implement emerging technologies, analytical tools, and digital solutions.
  • Drive innovation and technical decision-making to improve process performance and platform capabilities.
  • Monitor industry trends and incorporate scientific advances into development strategies.
  • Foster a collaborative and knowledge-sharing culture across the organization.

Qualifications

Required

  • PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Biological Sciences, or a related discipline with relevant industrial experience; or Master's degree with 6+ years of relevant industry experience; or Bachelor's degree with 8+ years of relevant industry experience.
  • Experience in cell culture process development within a biopharmaceutical CMC environment.
  • Strong understanding of cell culture media development, cellular metabolism, and upstream bioprocessing fundamentals.
  • Demonstrated interest in data analytics, process modeling, and data-driven process optimization.
  • Experience designing, executing, and interpreting laboratory studies using bioreactor systems.
  • Excellent scientific communication, problem-solving, and collaboration skills.
  • Working knowledge of current Good Manufacturing Practices (cGMP).

Preferred

  • Experience in metabolomics and systems-level process development.
  • Experience developing mechanistic, hybrid, or data-driven models for bioprocess development.
  • Familiarity with process automation, digital tools, data historians, and advanced analytics platforms.
  • Experience supporting clinical development programs and technology transfer activities.

What You'll Bring

  • A passion for technology-enabled innovation in upstream bioprocess development.
  • A data scientist mindset with the ability to extract insights from complex experimental datasets.
  • Strong teamwork and leadership capabilities in a highly collaborative, matrixed environment.
  • The ability to translate scientific findings into actionable process development strategies that improve robustness, scalability, and productivity.

Requirements

  • PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Biological Sciences, or a related discipline with relevant industrial experience; or Master's degree with 6+ years of relevant industry experience; or Bachelor's degree with 8+ years of relevant industry experience.
  • Experience in cell culture process development within a biopharmaceutical CMC environment.
  • Strong understanding of cell culture media development, cellular metabolism, and upstream bioprocessing fundamentals.
  • Demonstrated interest in data analytics, process modeling, and data-driven process optimization.
  • Experience designing, executing, and interpreting laboratory studies using bioreactor systems.
  • Excellent scientific communication, problem-solving, and collaboration skills.
  • Working knowledge of current Good Manufacturing Practices (cGMP).
  • Experience in metabolomics and systems-level process development.
  • Experience developing mechanistic, hybrid, or data-driven models for bioprocess development.
  • Familiarity with process automation, digital tools, data historians, and advanced analytics platforms.
  • Experience supporting clinical development programs and technology transfer activities.

Benefits

  • 401(k) Matching
  • Medical, Dental & Vision
  • Paid Time Off

Company overview

Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.

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