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.

Responsibilities

• 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.

Qualifications

• 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 (chromatography, depth/membrane filtration, ultrafiltration/TFF) and antibody-drug conjugates.

Education

• Bachelor’s or Master’s degree in a relevant scientific discipline (PhD preferred for the stated qualifications).

Skills

• Protein purification and downstream processing
• Chromatography, filtration technologies, and ultrafiltration/TFF
• Antibody-drug conjugate development
• Process development, scale-up, and technology transfer
• Regulatory documentation (CMC)
• Cross-functional collaboration and leadership
• Statistical design of experiments and data analysis
• Quality by Design concepts