Distinguished Research Scientist – Upstream Process Development

Role Summary

Distinguished Research Scientist – Upstream Process Development

Responsibilities

• Lead upstream process development for mammalian cell culture, including experimental design and analysis of fed-batch and intensified fed-batch operations, seed train expansion, and high-throughput bioreactor capabilities to optimize productivity and product quality.
• Drive technical innovation and platform development by introducing new technologies, leveraging industry expertise, and applying phase-appropriate risk strategies to accelerate protein production and support vaccines and biotherapeutics programs.
• Provide technical leadership and program oversight, including lab supervision, project management (scope, timelines, budget), and coordination with internal teams, manufacturing, and external collaborators to advance pipeline goals.
• Author and review critical documentation such as protocols, SOPs, batch records, technical reports, and tech transfer documents; deliver clear technical presentations to internal and external stakeholders.
• Support technology transfer and external partnerships by collaborating with CROs, CMOs, and consultants, establishing contracts, and ensuring effective knowledge transfer to manufacturing partners.

Qualifications

• PhD in engineering, biochemistry or other biotechnology related field plus 15 years of industry experience
• Experience working with mammalian cell culture of large molecule product streams (Monoclonal Antibodies, Proteins, Antigens‚Ķ.)
• Qualified candidates must be legally authorized to be employed in the United States

Skills

• Extensive upstream process development experience, including intensified fed-batch cell culture, perfusion, high-throughput screening, and process scale-up from development to manufacturing.
• Proven expertise in technology transfer and continuous bioprocess control strategies, ensuring robust, efficient, and scalable production processes.
• Strong regulatory background, with hands-on experience in cGMP and USDA-regulated environments, BSL-1 & BSL-2 labs, and participation in regulatory filings and submissions.
• Broad technical knowledge across multiple platforms, including fermentation, analytical method development, purification, and formulation technologies.
• Excellent problem-solving and collaboration skills, combining strategic and creative thinking with the ability to build strong partnerships and influence cross-functional teams and CDMOs.

Education

• PhD in engineering, biochemistry or related biotechnology field (required)

Additional Requirements

• Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment