Sr Scientist, Process Development

Role Summary

Sr Scientist, Process Development ponsible for leading downstream process development, mentoring technical staff, and driving technology innovations to improve purification platforms. Collaborates across teams to transfer processes to manufacturing and contribute to regulatory documentation.

• 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 downstream purification processes using chromatography, 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.
• Required:
  
  Proven track record in scaling up, transferring, and supporting purification processes from bench to pilot/commercial scale in GMP environments.
• Required:
  
  Experience with statistical design of experiments, advanced data analysis, process validation, and Quality by Design concepts.
• Required:
  
  At least 3+ years of experience supervising technical staff with strong management and leadership skills.
• Required:
  
  Excellent organizational skills and ability to manage multiple projects in a fast-paced environment.
• Required:
  
  Strong communication skills (verbal and written) and ability to build relationships across teams and with external partners.
• Preferred:
  PhD with at least 2 years of experience in biopharmaceuticals with expertise in protein purification and antibody-drug conjugates.

• Leadership and people management
• Downstream process development and scale-up
• Protein purification technologies (chromatography, depth/filtration, ultrafiltration/TFF)
• Antibody-drug conjugate development
• Process analytical thinking and DOE/advanced data analysis
• Regulatory documentation and CMC drafting
• Transfer to manufacturing and vendor/CMO collaboration
• Strong written and verbal communication

• BS degree in a relevant field (required)
• MS degree in a relevant field (required)
• PhD preferred (for the Preferred Qualifications)