Principal Research Scientist/Research Advisor-Analytical DevelopmentĀ
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
Direct Staffing Inc
https://careers.smartrecruiters.com/dstaff