Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. Must Have: Strong background supporting product development for late-stage products – Phase 3 and beyond (this is the most important skill). All manufacturing is outsourced to CDMOs: candidates must have strong CDMO oversight experience (not managing a team, but managing the program). Prior experience with regulatory dossiers and a clear understanding of what is needed for a product to succeed in late-phase development. Experience working with biologic products (must have). Respiratory experience (nice to have). Background in chemical development, process development, pharmaceutical sciences, or formulation. -------------------------------------------------------------------------------- The Associate Director / Senior Scientist of Product Development is a critical role responsible for key aspects of pharmaceutical development. The role focuses on late-stage development of a biologic/device combination product, including manufacturing process development, scale-up, validation, and critical product characterization and stability studies supporting clinical and BLA registration. Education and experience: Ph.D. in Pharmaceutical sciences, Chemical engineering, Biochemical engineering, or related fields. 6-10 years in lipid formulations, liposomes, or related drug-device delivery technologies (required). 2-5 years of manufacturing process development (lyophilization) is a plus. Extensive experience working with CDMOs is required. Late-stage product development experience is required. Experience authoring CMC dossiers for FDA, EMA, and other agencies is a must. Knowledge of drug-device development, inhalation drug delivery is a plus. Knowledge of GMP, ICH, FDA, Health Canada, and MHRA regulations is required. Excellent written and oral communication skills. Responsibilities: Leadership & Strategy: Oversee product development for biologics, proteins, and peptides, managing projects with CDMOs. Develop and execute strategies aligned with company goals and regulatory standards. Product Development: Conduct experiments to develop stable, effective drug products suitable for commercialization. Perform QbD studies to identify CQAs impacting product performance and stability. Conduct stability and characterization studies per ICH guidelines. Experience with lipid-based and/or protein-based biologics is required. Experience with lyophilization process development is a plus. CDMO/CMO Collaboration: Act as the main liaison with external manufacturing and analytical partners, ensuring communication and coordination meet project timelines and quality standards. Regulatory Compliance: Prepare and review documentation for INDs, BLAs, NDAs, ensuring compliance with cGMP and other regulations. Experience in authoring late-stage regulatory dossiers, especially BLAs, is required. Cross-Functional Collaboration: Collaborate with R&D, Manufacturing, Regulatory, and Quality teams to align product development with overall project goals. Troubleshooting & Problem Solving: Resolve formulation, process, and analytical issues during development and manufacturing, implementing corrective actions as needed. Ideal candidates will have the following skills: Technical Expertise: Experience with lipid-based products (including proteins) and drug-device combination products. Regulatory Knowledge: Deep understanding of IND and BLA submission processes and requirements. Leadership Skills: Proven ability to lead teams and operate effectively across organizations, with excellent interpersonal skills. Ability to challenge the status quo and encourage innovative thinking to address issues and opportunities.

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