Principal Research Scientist/Research Advisor-Analytical Development
Listed on 2026-02-28
-
Research/Development
Research Scientist -
Healthcare
Principal Research Scientist/Research Advisor-Analytical Development
- Full-time
Pharmaceutical / Biotech
Responsibilities:
The Principal Research Scientist/Research Advisor is responsible for analytical control strategies and leading a team in the development, qualification/validation, and use of analytical, bioanalytical, and characterization methods in support of biotherapeutic product development.
• Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP, and GMP requirements.
• Serve as key analytical technical lead for co-formulated drug products.
• Responsible for developing analytical strategies for co-formulated drug products.
• Develop all or portions of analytical control strategies.
• Develop and verify/qualify/validate analytical methods to support in-process, release, characterization analysis, and stability testing of active pharmaceutical ingredient and drug product.
• Provide support for discovery, toxicology, cell culture, purification, formulation, and manufacturing.
• Oversee method transfers to development, QCL, or third-party personnel.
• Coach, train, and manage performance of personnel (primarily, but not limited to, direct reports).
Basic Qualifications:
• Ph.D. in analytical, biophysical, biochemistry, molecular/cell biology, or related field.
• Minimum of 8+ years experience in analytical development in industrial, pharmaceutical, or biotech setting.
Additional Skills/Preferences:
• Experience with supervision, mentoring, and development of direct reports.
• Demonstration of scientific leadership skills.
• Effective oral and written communication skills.
• Ability to work productively in an interdisciplinary team environment.
• Experience with drug development process, including regulatory compliance.
• Fundamental knowledge of cGMP/GLP compliance requirements.
Candidate Details:
7+ to 10 years experience
Minimum Education - Doctorate Degree
Additional Details:
Location:
Indianapolis
Industry: Pharmaceutical/Biotech
Job Category:
Research & Development
Hours Per Week:
Full-time
Visa Candidate Considered:
No
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