Direct Staffing Inc
Principal Research Scientist/Research Advisor-Analytical Development
Direct Staffing Inc, Indianapolis, Indiana, us, 46262
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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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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