Director of Analytical Development

Director of Analytical Development 

Dragonfly Therapeutics is seeking a Director of Analytical Development to join our team. Responsibilities include the development, optimization, and tech transfer of analytical assays for release and characterization testing of clinical-stage bispecific antibodies, cytokines, and other protein-based therapeutics, with a focus on pivotal readiness. Additional duties involve authoring and reviewing CMC sections of regulatory filings and supporting documents. Collaboration with cross-functional teams is essential to ensure the successful execution of analytical workstreams and QC testing.

As a subject matter expert in analytical assay development for novel biologics, with a strong understanding of CMC cross-functional dynamics, you will be expected to provide strategic leadership and direction for analytical development activities. We are seeking a candidate with deep technical expertise in separations, mass spectrometry, biophysical and biochemical analyses. In this role, you will work closely with research, process development, manufacturing, regulatory, and quality teams to innovate and advance Dragonfly’s next-generation products. This is a unique opportunity for a dynamic leader to contribute their expertise as Dragonfly advances its clinical development portfolio.

Responsibilities (including but not limited to):

• Oversee the development, optimization, qualification, and tech transfer of analytical assays to the QC team and contract development and manufacturing organization (CDMO) partners for clinical-stage biological products, focusing on pivotal readiness
• Evaluate protocols, reports, risk assessments, and related procedures for regulatory compliance, technology transfer, and internal application
• Work with cross-functional teams in CMC, Quality, Regulatory, and Research departments, while coordinating with CDMOs to ensure proper assay implementation and analytical method execution
• Mentor and lead a team of scientists and technical specialists in the evaluation and implementation of analytical procedures relevant to product characterization and qualification testing
• Leverage expertise in biologics characterization methods (including mass spec) to develop product characterization packages
• Maintain a broad knowledge of established, emerging and highly innovative analytical tools and technologies

Qualifications:

• Bachelor's degree, Master's degree or PhD in Analytical Chemistry or related field with 10+ years of relevant industry experience
• Experience in CMC analytical development for biologics products
• Experience with method qualification, validation and comparability
• Industry experience in writing regulatory documents, including CMC sections of INDs. Experience writing technical protocols, reports, and procedures required
• Experience in transferring analytical assays into cGMP facility and serving as an SME with external CDMOs
• 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
• Excellent interpersonal, presentation, and written communication skills