Director, Drug Substance and Early Development
Dianthus Therapeutics, Inc.
Full-time
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Director, Drug Substance and Early Development overseeing early development activities for the clinical-stage biologics pipeline, including monoclonal antibodies and fusion proteins. Responsible for advancing drug substance development strategy, formulation, cell line development, bioreactor scale-up and tech transfer to ensure robust, scalable, and compliant processes for clinical and future manufacturing. Remote work option available for US-based candidates.
Responsibilities
- Lead MSAT activities for monoclonal antibodies and fusion proteins, from early development through clinical manufacturing.
- Oversee cell line development, clone selection, and characterization in collaboration with internal teams and external partners.
- Design and optimize bioreactor processes (shake flask to pilot scale) to ensure scalability, robustness, and regulatory compliance.
- Drive formulation development strategies for early-phase programs, ensuring compatibility with downstream processing and stability requirements.
- Collaborate cross-functionally with Analytical Development, Downstream Process Development, Quality, Regulatory, and Clinical Supply teams.
- Serve as a technical SME during tech transfer to CDMOs and during regulatory interactions.
- Author and review CMC sections of regulatory filings (IND/IMPD/BLA).
- Evaluate and implement new technologies to enhance upstream development capabilities.
Qualifications
- PhD in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience; or MS with 12+ years.
- Proven track record in upstream process development, cell line development, and bioreactor scale-up for biologics is highly preferred.
- Hands-on experience with monoclonal antibodies and/or Fc fusion proteins is required.
- Strong understanding of formulation development for early-phase biologics.
- Experience working with CDMOs and managing outsourced development/manufacturing activities.
- Familiarity with regulatory requirements for early- and late-stage biologics development.
- Excellent leadership, communication, and project management skills.