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Associate Director, Drug Product PD and Manufacturing

Waltham, Massachusetts, United States

Associate Director, Drug Product PD and Manufacturing

Reporting to the Executive Director, CMC Tech Ops, the Associate Director, Drug Product PD and Manufacturing, will provide strategic and technical leadership within the CMC Technical Operations team to support the development and optimization of Dragonfly’s drug product formulation and manufacturing. 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):

  • Participate in the development of liquid and lyophilized formulations to support Dragonfly’s pipeline (MAbs, bispecifics, cytokines)
  • Provide strategic and technical leadership in the development and execution of drug product strategies specifically development, optimization, scale-up, and manufacturing
  • Design and execute DP related development studies, including pre-formulation, formulation, and short-term stability in support of excursions during shipping and handling
  • 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
  • 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
  • 7+ years of relevant experience
  • Experience developing and transferring phase appropriate lyo and liquid formulations and manufacturing processes for biologics
  • Experience in managing activities at contract development and manufacturing organizations required
  • 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

About Dragonfly

Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas. 

Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.

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