Distinguished Research Scientist – Upstream Process Development

Role Summary

The Distinguished Research Scientist – Upstream Process Development leads the next generation mammalian cell culture strategies, characterizes and controls product quality, and develops robust upstream processes for Elanco’s early and late phase biomolecules, with initial emphasis on delivering therapeutic monoclonal antibody platforms. The role provides day-to-day technical and strategic leadership across upstream lab activities and serves as the lead scientist on CM&C, governance, and project teams within R&D and Manufacturing. It is expected to be an independent, influential leader for an upstream group, responsible for direct reports and establishing upstream processing strategy while supporting development activities and building GMP/USDA capabilities. Location: Indianapolis, IN (Hybrid).

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

• Required: PhD in engineering, biochemistry or other biotechnology related field plus 15 years of industry experience
• Required: Experience working with mammalian cell culture of large molecule product streams (Monoclonal Antibodies, Proteins, Antigens….)
• Required: Qualified candidates must be legally authorized to be employed in the United States
• Preferred: Extensive upstream process development experience, including intensified fed-batch cell culture, perfusion, high-throughput screening, and process scale-up from development to manufacturing.
• Preferred: Proven expertise in technology transfer and continuous bioprocess control strategies, ensuring robust, efficient, and scalable production processes.
• Preferred: 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.
• Preferred: Broad technical knowledge across multiple platforms, including fermentation, analytical method development, purification, and formulation technologies.
• Preferred: 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 other biotechnology related field