Sr Scientist, Process Development

Role

Senior Scientist in Cell Culture Process Development, focusing on pivotal and commercial stages for biologics, including monoclonal antibodies and novel modalities.

• optimize and characterize cell culture processes for supply during clinical trials and commercialization
• lead process risk assessments, process characterization, and support regulatory documentation such as BLA submissions
• Support technology transfer, investigate process improvements, design experiments across various bioreactors and platforms, and contribute to process validation and scale-up activities
• Mentor junior team members and collaborate cross-functionally with manufacturing sciences, regulatory, and other departments

• Bachelor's degree with 8+ years or Master’s degree with 6+ years of industry experience;
  PhD/PharmD with 3+ years preferred
• Technical expertise in cell culture, process development, bioreactor operation (shake flask to pilot scale), statistical modeling, and regulatory documentation
• Preferred skills include hands‑on experience with high‑throughput bioreactors, cell culture media development, process modeling, and experience with viral vaccines

High Value: biologics, monoclonal antibodies, cell culture process development, GMP, pivotal stage, regulatory submission support, cross‑functional collaboration, team leadership.

Work Setup:
On‑site with some travel to support technology transfers and external manufacturing oversight.