Senior Scientist II, Biologics Drug Product Development

Role Summary

Senior Scientist II, Biologics Drug Product Development in South San Francisco leading end-to-end formulation and process development for complex biologics. Plan and execute DoE-driven studies, assess clinical in-use stability, and model degradation pathways. Establish fit-for-purpose analytical strategies using protein characterization and stability methods, synthesize complex datasets into clear conclusions, and communicate results to technical, leadership, and regulatory audiences while upholding safety, data integrity, and GxP standards. A core focus is building efficiency at scale by devising high-throughput automated workflows and mentoring laboratory scientists within a cross-site team to accelerate and de-risk AbbVie’s biologics pipeline.

Responsibilities

• Conceive and execute novel scientific research and development that achieves project and functional area goals and provides novel approaches to answer scientific questions and enable development and characterization of biologic formulations.
• Understand and follow project strategic direction and ensure execution within study teams, seeking guidance when necessary.
• Generate new scientific proposals and lead efforts to drive innovation and implement strategies to increase efficiency and scientific depth.
• Develop and review detailed study plans to investigate, identify, develop, and optimize liquid and lyophilized drug products through design and execution of formulation, process development, and clinical in-use studies; utilize Design of Experiments (DoE) for planning experiments and modeling results.
• Accumulate and organize experimental data, make appropriate recommendations for analyzing and interpreting results, and communicate findings to various audiences in scientific presentations, technical reports, and regulatory documents.
• Maintain hands-on experience in developing models for and characterizing biologic degradation pathways and introducing robust analytical approaches and techniques for characterization.
• Adhere to corporate standards regarding code of conduct, safety, handling of materials, controlled drug, and GxP compliance where applicable.
• May mentor/supervise a team and be accountable for the effective performance of team members.
• Generate high-quality data based on sound scientific principles and document results in electronic lab notebook.
• Communicate effectively to various audiences and relay concise, consistent messages.
• Represent the function within cross-functional and cross-site technical teams.

Qualifications

• Strong technical background in formulation principles, drug product degradation pathways, drug product lyophilization and processing, and deep understanding of characterization approaches.
• Hands-on experience in analytical techniques used for protein characterization and stability testing (e.g., SEC, CE-SDS, icIEF, HIAC, MFI, DLS, etc.).
• Demonstrated ability to create automated workflows and successfully implement them in a cross-matrixed team with tangible efficiency results.
• Strong computational/programming skills to facilitate automation of workflows and data processing (Hamilton liquid handlers or other automation instruments).
• Detail-oriented and highly organized with a demonstrated ability to drive innovative science and solve complex problems.
• Technical experience with developing fit-for-purpose analytical characterization techniques and drug product presentations.
• Prior experience in the development of high-throughput screening workflows for protein formulation development and/or analytical characterization.
• Experience in managing and developing laboratory scientists.
• Excellent communication and written skills.

Education

• Education: Bachelor’s Degree with 12+ years of experience, Master’s Degree with 10+ years of experience, or PhD with 4+ years of experience in the biotechnology or pharmaceutical industry.