Director, Drug Product PD and Manufacturing

Director, Drug Product PD and Manufacturing

Dragonfly Therapeutics is seeking a Director, Drug Product PD and Manufacturing, to provide strategic and technical leadership within the CMC Technical Operations team. This role will be responsible for formulation development, DP manufacturing process development, in-use stability, technology transfers, and management of DP CDMOs. The successful candidate will be a key member of Dragonfly’s talented CMC team and plan an important role in bringing novel therapies to patients.

Responsibilities (including but not limited to):

• Provide strategic and technical leadership in the development and execution of drug product strategies specifically development, optimization, scale-up, and manufacturing
• Provide support to Tox and clinical studies by evaluating in-use stability and material compatibility according to intended administration parameters
• Manage and oversee activities at contract manufacturing organizations to ensure compliant and robust manufacturing processes are both developed and/or maintained
• Provide oversight of project milestones, drive activities with additional project team members, manage timelines, contracts and invoices, and accountability for all DP programs
• Design and execute DP related development studies, including pre-formulation, formulation, and short-term stability in support of excursions during shipping and handling
• Participate in the development of liquid and lyophilized formulations to support Dragonfly’s pipeline (MAbs, bispecifics, cytokines)
• Ensure timely production of clinical drug inventory to support clinical supply
• Collaborate with the appropriate stakeholders from Program Management, R&D, process and analytical development, Supply Chain, Quality, and Clinical to contribute to ensure delivery of drug product on-time with the appropriate product quality attributes
• Support deviations/investigations, change controls, and authoring/review/approval of protocols, pharmacy manuals, reports and relevant sections of regulatory submissions
• Author, review and approve technical protocols and reports including applicable regulatory sections

Qualifications:

• Bachelor’s, Master’s, or Ph.D. Degree in Chemistry, Biochemistry, Chemical Engineering or a related discipline (title commensurate with experience)
• 7+ years of relevant experience
• Experience developing and transferring phase appropriate lyo and liquid formulations and manufacturing processes for biologics
• Working knowledge of relevant ICH guidelines, GMPs and global regulatory requirements.
• Strong collaboration and communication skills
• Experience planning and executing in-use stability and long-term stability studies
• 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