Principal Research Scientist​/Research Advisor-Analytical Development

Principal Research Scientist/Research Advisor-Analytical Development

Pharmaceutical / Biotech

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).

• 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

All your information will be kept confidential according to EEO guidelines.