Senior Scientist I, Biologics Drug Product Development

Key Responsibilities

• Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
• Support scale-up and technology transfer activities to internal and external manufacturing sites.
• Keep abreast of the latest advances in biologics formulation and process technologies.
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.
• May represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
• Effectively and timely communicate study plans, risks and mitigation plans to stakeholders and line management.

Qualifications

• Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 8+ (Bachelors), 6+ (Masters), or 0+ (PhD) years of relevant industry experience.
• 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.

Preferred Qualifications

• Understanding of relevant cGMP and regulatory guidance.
• Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale-up and technology transfer.
• Experience in managing third party manufacturers.
• Experience with quality risk management and drug product control strategies.