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Associate Director, Biologics Development (Remote / Home Based)
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Full-time
Remote
- The successful candidate will have deep understanding of liquid and lyophilized formulation development for biologics, protein degradation pathways, biophysical characterization studies, drug product process development, tech transfer, process characterization, risk assessment and implementation of control strategies.
- Provide subject matter expertise (SME) in Biologics Formulation and DP process development including lyophilized presentation development.
- Support tech transfer of biologics drug product processes to commercial scale contract manufacturing organizations (CMOs)
- Serve as Person in Plant (PiP) during batch production to act as liaison between manufacturing facility and Biologics drug product team
- Strong knowledge of protein and peptide formulation development techniques, stability assessment, forced degradation studies, biophysical characterization techniques.
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