Biopharma Analytical Transfer Scientist

Elanco; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Elanco, a global leader in animal health, is seeking a Research Scientist for the Biopharma Technical Development Analytical Development team to lead analytical transfer activities.

You will collaborate with AD/PD SMEs, internal teams, and external CROs/CDMOs to ensure timely transfer, qualification, and lifecycle support for biologics programs, while ensuring GMP/GRP compliance and clear communication to leadership.

Qualifications

• Ph.D. in biology, analytical chemistry, biochemistry, or related field with 2+ years pharma experience.
• Experience with analytical method lifecycle for biologics: transfer, qualification, validation, troubleshooting.
• Experience with external vendors, CROs, and CDMOs.
• Strong technical writing and cross-functional collaboration.

Responsibilities

• Oversee analytical method transfer activities for biopharmaceuticals to labs, CROs, and CDMOs.
• Serve as embedded analytical representative within project teams.
• Provide oversight across the method lifecycle: transfer, qualification, validation, troubleshooting, lifecycle support.
• Collaborate with sending/receiving site SMEs to ensure scope alignment and acceptance criteria.
• Manage relationships with external vendors and rapid escalation of risks and issues.
• Evaluate data and trends to identify risks and mitigation strategies.
• Prepare, review, and edit documents ensuring GMP/GRP compliance.
• Communicate progress, decisions, and risks to leadership.
• Collaborate with QA and Regulatory to meet internal and global standards.
• Support readiness for clinical supply, registration, and commercial supply.

Skills

Analytical methods

HPLC

CE

ELISA

Technical writing

Cross-functional

Risk assessment

Education

Ph.D. in biology/analytical chemistry/biochemistry

M.S. in related field

B.S. in related field

Tools

HPLC equipment

DoE statistics

CRO/CDMO management

Job description

Elanco, a global leader in animal health, is seeking a Research Scientist for the Biopharma Technical Development Analytical Development team to lead analytical transfer activities.

You will collaborate with AD/PD SMEs, internal teams, and external CROs/CDMOs to ensure timely transfer, qualification, and lifecycle support for biologics programs, while ensuring GMP/GRP compliance and clear communication to leadership.