Director, Drug Product Development

<div> <p class="MsoNormal"><strong>Director, Drug Product Development</strong></p> <p class="MsoNormal"> <p class="MsoNormal">This role is responsible for the following responsibilities:</p> <p class="MsoNormal">· Serve as the expert in the development and production of drug products utilizing prefilled syringes.<br />· Establish strategies for late-phase and commercial launch of prefilled syringe products.<br />· Manage tech transfer, process development, and GMP manufacturing operations for drug products, including on-site support.<br />· Supervise the performance of CDMOs to ensure compliance with timelines and deliverables.<br />· Implement QbD principles for risk assessments and manufacturing strategies throughout the development process.<br />· Collaborate with teams working on vials, prefilled syringes, autoinjectors, and other innovative delivery methods.<br />· Collaborate with Quality and external partners on regulatory submissions and batch reviews.</p> <div> </div> <p class="MsoNormal"><strong>The successful candidate will have the following qualifications:</strong></p> <p class="MsoNormal"> <div>· Over 10 years of experience in drug product development and manufacturing.</div> <div>· Minimum of 5 years in clinical and/or commercial GMP operations for prefilled syringe products.</div> <div>· Demonstrated leadership in GMP manufacturing of combination products.</div> <div>· Expertise in biologics process development and aseptic manufacturing, particularly mAbs.</div> <div>· Experience managing relationships with CDMOs and overseeing tech transfers and GMP activities.</div> <div>· Familiarity with PPQ, biologics commercialization, and PAI readiness.</div> <div>· Experience in extractables/leachables risk assessments is a plus.</div> </div>