Sr Scientist, Process Development

Role Summary

Sr Scientist, Process Development responsible for leading downstream process development, mentoring technical staff, and driving technology improvements in protein purification and antibody-drug conjugates. The role involves designing experiments, transferring processes to manufacturing sites, and contributing to regulatory documentation and cross-functional initiatives.

• Lead, mentor, coach, and develop technical staff within and outside the group in all aspects of downstream process development, including protein purification, bioconjugation (antibody-drug conjugates), and new technology implementation.
• Design and execute experiments to develop efficient, effective downstream purification processes using multiple chromatography modes, filtration technologies, and ultrafiltration/TFF.
• Drive new technology development and implementation to enhance downstream platforms and improve process efficiency.
• Author and review technical documents, development reports, SOPs, manufacturing batch records, and CMC sections of regulatory submissions (IND, INDa, BLA).
• Transfer downstream processes to manufacturing sites, CMOs, and partner sites, ensuring successful scale-up and implementation.
• Represent Downstream Process Development on cross-functional teams and contribute to strategic initiatives.
• Produce significant internal/external documents or publications supporting company goals.

• Required:
  
  BS degree with at least 8 years of industry experience in biopharmaceuticals with expertise in protein purification (chromatography, depth/membrane filtration, ultrafiltration/TFF) and antibody-drug conjugates.
• Required:
  
  MS degree with at least 6 years of industry experience in biopharmaceuticals with expertise in protein purification (chromatography, depth/membrane filtration, ultrafiltration/TFF) and antibody-drug conjugates.
• Required:
  
  Familiarity with protein conjugation process chemistry and formulation.
• Required:
  
  Hands‑on experience in protein purification, thorough understanding of chromatography, and familiarity with AKTA systems.
• Required:
  
  Extensive knowledge of impurity removal strategies and product variant control; strong chromatography and/or conjugation experience preferred.