Scientist L, Biologics Drug Product Development

The Biologics Drug Product Development group develops monoclonal antibodies, antibody drug conjugates (ADC), and other biologics using state of the art formulation and process technologies. We create valuable intellectual property via new formulation compositions, cost effective manufacturing processes, and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.

We are seeking a motivated and experienced Scientist for Biologics Drug Product formulation and process development. The candidate will independently design and develop stable and robust Drug Product formulations and scalable manufacturing processes for biologics used in both clinical trials and commercial products. This individual will be an integral part of the Drug Product Development and CMC teams. The position is highly collaborative across functions such as preformulation, analytical, process engineering, internal and external manufacturing, Operations S&T, and Commercial Manufacturing. The individual will work to define formulation and manufacturing processes for a range of biologic Drug Products.

Key Responsibilities:

• Design and execute the formulation and Drug Product Development activities of the assigned compounds. This will include formulation and commercial process development for biologics (monoclonal antibodies, antibody drug conjugates, bispecifics and fusion proteins).
• Perform lab-based studies including study design, preparation, execution, data collection, analysis, presentation, and report writing.
• Partner with manufacturing sites to enable smooth technical transfer from lab to pilot to commercial scale.
• Generate original technical ideas for formulation and process technologies for assigned biologics.
• Integrate into assigned pipeline project teams as a key contributing member. Actively participate on cross-functional teams within Biologics Development.
• Stay current with relevant scientific literature and lead new scientific initiatives. Publish scientific papers and external presentations to influence the pharmaceutical industry.
• Prepare concise and sound scientific presentations of experimental results.
• Authoring of comprehensive, scientifically sound reports, e.g. development reports or risk assessments that serve as source documents for regulatory submissions. Author portions of regulatory submissions to designated health authorities related to these reports.
• Maintain absolute compliance with all relevant work safety and quality requirements.

Minimum Qualifications:

• Bachelors, Masters, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines with 5 (Bachelors), 2 (Masters), or 0 (PhD) years of relevant industry experience.
• Strong laboratory skills and experience focused on formulation and process development for monoclonal antibodies, antibody constructs/conjugates or other biologics.
• Scientific problem solving, experimental design, and trouble shooting skills.
• Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling and lyophilization for liquid and lyophilized products.
• Experience in laboratory documentation systems, including ELN, and experience with technical report writing.

Key Leadership Competencies 

• Effectively communicates to influence others and pulls together ideas from disparate areas.
• Builds strong relationships with peers and cross-functional partners to maximize performance.
• Creates a learning environment and is open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation, and manages innovation to reality.
• Enhances our culture by modeling inclusive leadership and team-oriented behaviors.
• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks, identify problems and work toward solutions rapidly, and maintain a productive mindset amongst change.