Senior Research Scientist, Biologics Drug Product Formulation & Sterile Process Development

Key Responsibilities

• Lead the design and development of biologics formulations, utilizing high-throughput screening (HTS) platforms to rapidly evaluate excipient compatibility and physical-chemical stability.
• Implement and oversee automated equipment/workflows to improve efficiency.
• Apply AI/ML modeling and predictive analytics to streamline formulation selection, optimize stability profiles, and significantly reduce development cycles.
• Leverage knowledge/experience to scale-up and develop a robust sterile manufacturing process.
• Lead and execute the technical transfer of drug product formulations and manufacturing processes from R&D to clinical and internal commercial manufacturing sites.
• Lead the Manufacturability Review process, ensuring the delivery of an effective process/product control strategy.
• Play a leadership role in material delivery activities for pivotal CT and registration stability supply.
• Lead troubleshooting activities related to parenteral formulation stability, sterility, and manufacturing deviations.
• Effectively apply QbD principles throughout the development lifecycle to ensure manufacturing concerns are addressed at phase-appropriate points.
• Write, review or approve high quality technical reports, batch records and global regulatory submissions.
• Provide technical oversight for Contract Research/Manufacturing Organizations (CRO/CMO) and external consultants.
• Work effectively across all R&D teams, manufacturing and with external collaborators.

Basic Qualifications

• Ph.D. in pharmaceutical sciences/ biochemistry/chemical/bio engineering or related field with a minimum of 5 years relevant experience or MS +10 years relevant experience in the pharmaceutical/biotech industry, specifically in biologics formulation and sterile manufacturing.
• Qualified candidates must be legally authorized to be employed in the United States.

Additional Skills/Preferences

• Prior relevant process/product commercialization experience with a focus on process robustness/reliability and effective control strategy development.
• Experience working within a cGMP-regulated environment.
• Familiarity with using machine learning algorithms or predictive modeling software to accelerate drug product development.
• Hands-on experience with automated platforms (e.g., liquid handlers, robotic samplers) and plate-based high-throughput tools.
• Experience in multiple technology platforms (e.g. lyophilized products, lipid nanoparticles, adjuvanted formulations).
• Strong strategic thinking skills with a track record of using innovative technologies to solve complex formulation challenges.
• Strong interpersonal skills and proven ability to lead project teams and influence cross-functional partners in R&D, Manufacturing, and Quality.