Associate Director of Downstream Process Development

Associate Director of Downstream Process Development

Dragonfly Therapeutics is seeking a Downstream Process Development expert to join our team. This position will provide key technical leadership in advancing our internal DSP capabilities for the purification of bispecific antibodies, cytokines, and other protein-based therapeutics. We are looking for someone with strong technical expertise in the development and optimization of downstream processes for the production of novel biologics. The individual in this role will be responsible for design, scale-up, and transfer purification processes from laboratory scale to manufacturing, ensuring compliance with regulatory guidelines and meeting project timelines. The ideal candidate will have extensive experience in chromatography, filtration, as well as a strategic vision for developing innovative solutions in downstream processing. This is a great opportunity for the right individual to bring their leadership and capabilities to Dragonfly as we advance our clinical development portfolio.

Responsibilities (including but not limited to):

• Oversee the design, development, and optimization of downstream processes, including purification methods like chromatography (affinity, ion exchange, size exclusion, etc.), filtration, and ultrafiltration/diafiltration
• Lead efforts in process scaling and technology transfer from Dragonfly PD to external GMP manufacturing vendors, ensuring robust and reproducible results
• Mentor junior scientists both within CMC as well as across the broader Biologics team
• Support preclinical and IND-enabling material production needs in collaboration with the research team
• Oversee the product lifecycle, from feasibility studies to full-scale production, ensuring timely delivery and alignment with project milestones
• Identify opportunities for innovation and improvement in downstream processes, driving cost-effective and scalable solutions
• Collaborate with cross-functional teams including protein sciences, upstream development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and process success
• Establish strong relationships and foster collaboration both internal at Dragonfly and with external partners
• Author and review technical and scientific documents including but not limited to study protocols, reports, manufacturing batch records, sections of regulatory filings, and SOPs

Qualifications:

• Master's or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with 7+ years of experience in downstream process development (title commensurate with experience)
• At least 3 years in a leadership role within the biopharmaceutical industry (biotech strongly preferred)
• Strong expertise in the purification of biologics, including monoclonal antibodies, proteins, viral vectors, or similar biologics
• Experience with scale-up and technology transfer to GMP manufacturing
• Experience designing viral clearance studies
• Extensive knowledge of downstream purification techniques (e.g., chromatography, filtration) and associated analytical methods
• Proven track record of supporting IND-enabling studies and regulatory submissions
• Familiarity with automated process development tools and high-throughput screening technologies
• Experience working with CDMOs and external manufacturing partners
• Experience with process characterization, validation, and PPQ run support is a plus
• Working knowledge of relevant ICH guidelines, GMPs and global regulatory requirements
• Excellent verbal and written communication skills, demonstrated creativity, strong interpersonal and collaborative skills
• Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities
• Independently motivated, detail-oriented, and “can-do” attitude
• Approximately 10% travel in support of manufacturing activities at the CDMOs