Role OverviewLead biologics drug product formulation and process development, characterization, and robustness studies. Support scale-up and technology transfer activities. Keep abreast of the latest advances in biologics formulation and process technologies.
What You Will Do
Design and execute biologics formulation and process development, characterization, and robustness studies. Communicate study plans, risks, and mitigation plans to stakeholders and line management.
Why It Might Be a Fit
Proven ability to solve critical scientific problems, hands-on experience with biologics formulation development, and understanding of biologics degradation mechanisms and stabilization strategies.
Requirements
- Proven ability to solve critical scientific problems
- Hands-on experience with biologics formulation development
- Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods
- Solid understanding of biologics degradation mechanisms and stabilization strategies
- Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses, and data visualization tools
- Understanding of relevant cGMP and regulatory guidance
- Experience with sterile manufacturing unit operations (freez-thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale-up, and technology transfer
- Experience with quality risk management and drug product control strategies
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