Senior Drug Substance Scientist

Summary

Join Dianthus Therapeutics, a clinical-stage biotechnology company focused on developing novel monoclonal antibodies, as the Director, MSAT. You will play a key role in optimizing antibody manufacturing processes, ensuring quality, efficiency, and regulatory compliance. Reporting to the Senior Director, Drug Substance and MSAT, you will oversee upstream and downstream process development for biologics drug substance production. This role involves leading drug substance manufacturing, managing and troubleshooting production releases, PPQ, and collaborating with internal and external partners. This is a remote position within the United States, offering the opportunity to contribute to an innovative pipeline and work with cutting-edge technology.

Requirements

• PhD or master’s in Biology, Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 8+ years of relevant industry experience
• Extensive experience in downstream (e.g., chromatography, filtration) drug substance process development for biologics, and antibody experience is preferred
• Proven track record of successful technology transfers and scale-up to cGMP manufacturing
• Experience with late-stage process development and regulatory (BLA) submissions
• Strong knowledge of antibody purification technologies and quality control measures
• Familiarity with QbD (Quality by Design) principles and risk-based process development
• Proficiency in data analysis and process modeling tools
• Strong problem-solving and decision-making skills
• Excellent communication and collaboration abilities
• High sense of accountability to deliver results and meet timelines
• Proven ability to work in a fast-paced, dynamic startup environment

Responsibilities

• Design, plan, and execute Process Performance Qualification (PPQ) activities to support late-stage upstream and downstream process characterization and validation
• Ensure process robustness and consistency through statistical analysis and data-driven approaches
• Prepare and review PPQ protocols and reports for regulatory submissions
• Lead the development, optimization, and scale-up of upstream and downstream processes for antibody drug substance production
• Collaborate with cross-functional teams to integrate upstream and downstream workflows seamlessly
• Develop and optimize purification processes, including chromatography, filtration, and other separation technologies for antibodies
• Establish scalable and robust downstream processes to ensure high yield and purity of drug substance
• Oversee the transfer of processes to manufacturing facilities, ensuring alignment with regulatory requirements and commercial scalability
• Work closely with CMOs/CDMOs to support late-stage development and commercialization activities
• Collaborate with analytical development teams to define critical quality attributes (CQAs) and establish in-process controls
• Ensure consistency in process performance through data-driven approaches and risk assessments
• Author and review sections of regulatory filings related to drug substance processes, such as INDs, BLAs, or MAAs
• Stay up-to-date on regulatory guidelines to ensure compliance in all process development activities
• Provide technical leadership to the team and mentor junior scientists and engineers
• Promote a culture of innovation, collaboration, and continuous improvement

Preferred Qualifications

Experience with upstream process development is highly preferred

Benefits

• We are open to the position being based remotely within the United States
• We are open to you working remotely