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-timePharmaceutical / BiotechResponsibilities: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 for 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.• Minimum 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 experienceMinimum Education - Doctorate DegreeADDITIONAL DETAILS:Location: IndianapolisIndustry:Job Category: Research & DevelopmentHours Per Week:Visa Candidate Considered: NoAll your information will be kept confidential according to EEO guidelines.
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Full-timePharmaceutical / BiotechResponsibilities: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 for 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.• Minimum 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 experienceMinimum Education - Doctorate DegreeADDITIONAL DETAILS:Location: IndianapolisIndustry:Job Category: Research & DevelopmentHours Per Week:Visa Candidate Considered: NoAll your information will be kept confidential according to EEO guidelines.
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