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
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