Additionalinformation

Additional Information

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Companydescription

Company Description

Pharmaceutical / Biotech

Jobdescription

Job Description

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

Qualifications

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