Job Description
Job Description – Biologics Formulation & Drug Product Development
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- Develop and optimize protein/biologic formulations for parenteral drug products.
- Perform hands-on formulation screening involving buffers, pH, excipients, surfactants, and stabilizers.
- Conduct protein characterization to assess purity, aggregation, degradation, and stability.
- Design and execute biologic stability studies under various storage and stress conditions.
- Support parenteral drug product development for injectable biologics.
- Apply knowledge of sterile injectable manufacturing and aseptic processing.
- Conduct preformulation, formulation optimization, and drug product development studies.
- Analyze formulation and analytical data and troubleshoot protein stability or formulation issues.
- Collaborate with analytical, process development, manufacturing, quality, and regulatory teams.
- Experience with mAbs/recombinant proteins, lyophilization, SEC-HPLC, CE-SDS, DLS, DSC, and GMP/GLP is highly preferred.
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