Principal Research Scientist/Research Advisor-Analytical Development
This role demands deep expertise in developing and validating analytical methods for biotherapeutics, ensuring compliance with stringent regulatory standards like GLP and GMP while leading cross-functional teams. The Principal Research Scientist will bridge technical innovation with quality control, shaping analytical strategies for co-formulated drug products throughout their lifecycle.
Skills required
About this role
Principal Research Scientist/Research Advisor-Analytical Development
Responsibilities:
The Principal Research Scientist/Research Advisor is responsible for analytical control strategies and for 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 co-formulated drug products.
• Responsible for development of analytical strategies for co-formulated drug products
• Develop all or portions of analytical control strategies.
• Development and verification/qualification/validation of 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.
• Oversight for method transfers to development, QCL, or third party personnel.
• Coaching, training, and administration of performance management to personnel (primarily, but not limited to, direct reports).
Basic Qualifications
• Ph.D. in analytical, biophysical, biochemistry, molecular/cell biology, or related field
• Minimm of 8+ years experience in analytical development in industrial, pharmaceutical or biotech setting
Additional Skills/Preferences
• Experience with the supervision, mentoring and development of direct reports.
• Demonstration of scientific leadership skills.
• Effective oral and written communication skills.
• Must be able to work productively in an interdisciplinary team environment.
• Experience with the drug development process, including knowledge of regulatory compliance issues.
• Fundamental knowledge of cGMP/GLP compliance requirements.
CANDIDATE DETAILS
7+ to 10 years experience
Minimum Education - Doctorate Degree
.
ADDITIONAL DETAILS
Location: Indianapolis
Industry:
Job Category: Research & Development
Hours Per Week:
Visa Candidate Considered: No
Qualifications
Basic Qualifications
• Ph.D. in analytical, biophysical, biochemistry, molecular/cell biology, or related field
• Minimm of 8+ years experience in analytical development in industrial, pharmaceutical or biotech setting
Additional Information
All your information will be kept confidential according to EEO guidelines.
