Senior Scientist, I

Role Summary

Senior Scientist I to join the Biologics Drug Product Development group at AbbVie's Bay Area site in South San Francisco, CA to lead end-to-end formulation and process development. In this role, you will plan and execute DoE-driven studies, assess clinical in-use stability, and model degradation pathways. You will establish fit-for-purpose analytical strategies using protein characterization and stability methods such as SEC, CE-SDS, icIEF, HIAC, MFI, and DLS. A core focus of the role is building efficiency in drug product manufacturing at scale by devising, deploying, and optimizing high-throughput automated workflows across a matrixed, cross-site environment.

Responsibilities

• Develop stable and fit-for-purpose liquid and lyophilized drug products through the design and execution of formulation, process development, and clinical in-use studies.
• Support testing of representative stability lots to support drug substance and drug product shelf-life extension.
• Generate high-quality data based on sound scientific principles and document results in electronic lab notebook.
• Responsible for accumulating and organizing experimental and other relevant data, making appropriate recommendations for analyzing and interpreting results, and effectively communicating finds to various audiences in scientific presentations, technical reports, and regulatory documents
• Formulate conclusions and design follow-on experiments based on multidisciplinary data.
• Drive innovation and continuously enhance capabilities and business processes within the organization.
• Initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
• Work efficiently and collaboratively in an agile team setting with minimal direction from supervisors.
• Represent the function within cross-functional and cross-site technical teams.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug, and GxP compliance where applicable.

Qualifications

• Ph.D. in chemical engineering, pharmaceutical sciences, material science, analytical sciences or equivalent field with 0-3 years of experience or BS/MS degree with 8-10 years of relevant experience in the biotechnology or pharmaceutical industry.
• Strong technical background in protein formulation principles, drug product degradation pathways, drug product lyophilization, drug product manufacturing process unit operations and characterization approaches.
• Hands-on experience in analytical techniques used for protein characterization and stability testing preferred (e.g., SEC, CE-SDS, icIEF, HIAC, MFI, DLS, etc.).
• Technical experience with developing fit-for-purpose analytical characterization techniques is desired.
• Prior experience in the development of protein product formulations is highly desirable.
• Detail-oriented and highly organized with a demonstrated ability to drive innovative science and solve complex problems.
• Excellent communication and written skills