Distinguished Research Scientist – Upstream Process Development

Elanco • Indianapolis, IN

8d • Hybrid

About The Position

The Upstream Senior Research Scientist (Technical Development) directly supports Elanco’s Technical Development (TD) organization in its mission to develop and deliver Innovation, Characterization, and Process Control. The primary responsibilities of this role are to support the upstream (mammalian cell culture) scientific team by developing, optimizing, and characterizing cell culture processes that produce recombinant vaccines, proteins, and antibodies. This role supports upstream lab activities within the broad scope of Elanco’s large molecule portfolio with initial emphasis on delivering Elanco’s therapeutic monoclonal antibody platforms.

Requirements

• PhD in Engineering, Biochemistry, or other biotechnology-related degree
• Minimum of 5 years of experience working with mammalian cell culture of large molecule product streams (monoclonal antibodies, proteins, antigens)
• Experience with fed-batch cell culture and leading other scientists
• Experience with cell culture scale-up and technology transfer
• Experience working in regulated environments (e.g., cGMP, USDA) and BSL-1 and BSL-2 laboratories
• Strong interpersonal skills with demonstrated ability to collaborate with and influence teams
• Experience designing experiments using statistical approaches involving biological systems

Nice To Haves

• Experience with fed-batch, perfusion, and/or intensified fed-batch cell culture
• Experience with cell culture scale-up and technology transfer
• Experience working in regulated environments (e.g., cGMP, USDA) and BSL-1 and BSL-2 laboratories
• Strong problem-solving skills, including strategic and creative thinking
• Understanding of or experience with multiple technology platforms (e.g., fermentation, analytical method development, purification, formulations)
• Strong interpersonal skills with demonstrated ability to collaborate with and influence teams
• Strongly preferred: experience within the Animal Health industry
• Experience interacting with applicable regulatory agencies (FDA, USDA, EMA)
• Experience with quality standards such as GMP

Responsibilities

• Lead a small group (1–3) scientists and ensure team members are growing scientifically and professionally through direct and indirect coaching and mentorship
• Technical program leadership
• Incorporate safety and quality into process development
• Incorporate DoE-based approaches into design and analysis of cell culture experiments
• Collaborate with internal and external partners and technology transfer with manufacturing partners
• Author, review, and execute protocols, batch records, and technical reports
• Provide subject matter expertise to mammalian cell culture processes and seed train expansion, leveraging knowledge and experience to accelerate and optimize protein production
• Introduce new techniques and technologies to the TD organization and maintain awareness of advancements in the field and competitive landscape
• Conduct prospective capacity planning and program planning for resources under supervision

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees