Job Details

• 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)
• Preferred background in chemical development, process development, pharmaceutical sciences, or formulation

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The Associate Director / Senior Scientist of Product Development is a critical role and will be responsible for key aspects of pharmaceutical development. The role will focus on late-stage product development of a biologic / device combination product, inclusive of manufacturing process development and scale up / validation, and critical product characterization and stability supporting clinical and BLA registration studies.

• Education and experience:Ph.D. in Pharmaceutical sciences, Chemical engineering, Biochemical engineering or related field.
• 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 regulatory agencies is a must.
• Knowledge and experience in drug-device development, inhalation drug delivery is a plus.
• Knowledge of Good Manufacturing Practices, ICH, FDA, Health Canada and MHRA Regulations is required
• Excellent written and oral communication skills.

• Key Responsibilities:Leadership & Strategy: Oversee product development for biologics, proteins, and peptides, managing projects with CDMOs. Develop and execute strategies aligned with company mission and regulatory standards.
• Product Development: Research, design and execute controlled experiments, with high attention to detail to development of stable and effective drug product, fit for commercialization. Conduct QbD experiments to identify CQAs that impact product performance and stability. Conduct registration enabling stability studies and product characterization studies per appropriate ICH guidance's. Experience working on lipid based and / or protein-based biologics is required. Experience with lyophilization process development and optimization is a plus.
• CDMO/CMO Collaboration: Serve as the primary liaison with external manufacturing / analytical partners. Ensure effective communication and coordination to meet project timelines and quality expectations.
• Regulatory Compliance: Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to cGMP and regulatory requirements. Experience authoring late-stage regulatory dossiers, particularly BLAs is required.
• Cross-Functional Collaboration: Work closely with R&D, Manufacturing, Regulatory, and Quality Assurance teams to integrate product development within overall project goals.
• Troubleshooting & Problem Solving: Address and resolve formulation, process optimization, analytical issues during development and manufacturing. Implement corrective and preventive actions as needed.

• Ideal candidates will have the following skills:
• Technical Expertise: Experience with lipid-based products (including proteins) and drug-device combination products is required.
• Regulatory Knowledge: Deep understanding of regulatory requirements and submission processes for IND and BLA.
• Leadership Skills: Proven ability to lead and develop high-performing teams with excellent interpersonal and communication skills.
• Proven ability to operate effectively across a matrix organization to drive programs according to timelines; ability to articulate project objectives and priorities
• Must be comfortable and confident challenging the status quo and pushing the teams to look at issues and opportunities from all angles