Senior Scientist, Product Development

Our client is dedicated to revolutionizing care for acute and critically ill patients by developing innovative inhaled drug/biologic and device combination products. Bring your expertise in biologic and device combination products, analytical development, and regulatory strategy to a company at the forefront of neonatal care breakthroughs.

Our client is dedicated to revolutionizing care for acute and critically ill patients by developing innovative inhaled drug/biologic and device combination products. They are seeking a talented Senior Scientist to drive late-stage product development and regulatory excellence.

This is your opportunity to be part of a passionate, expert-driven team steering medical innovation that has the potential to change lives. Bring your expertise in biologic and device combination products, analytical development, and regulatory strategy to a company at the forefront of neonatal care breakthroughs.


What you'll do:

• Lead pharmaceutical development activities, including data generation, product characterization, and process optimization.
• Prepare and review regulatory submission documents such as INDs, BLAs, and NDAs, ensuring full compliance with cGMP standards.
• Manage analytical method development, validation, and transfer for lipids, proteins, and peptides, with a focus on robustness and industry standards.
• Design and oversee stability studies to establish product shelf life for clinical and commercial use.
• Collaborate closely with external CDMOs and CMO partners to ensure timely, high-quality project execution.
• Work cross-functionally with R&D, Manufacturing, Regulatory, and Quality teams to align development strategies with regulatory requirements and business goals.
• Troubleshoot complex analytical issues and implement corrective actions to maintain project momentum.

Required Skills:

• 5-10 years of late-stage product development experience in pharmaceuticals.
• Proven expertise in authoring CMC sections for regulatory agencies such as FDA and EMA.
• Strong background in analytical chemistry, biochemistry, or related fields (M.Sc. or Ph.D.).
• Deep understanding of regulatory processes and submission preparation.
• Experience managing external labs and CDMOs.
• Knowledge of cGMP practices and sterile manufacturing processes.
• Proficiency with analytical techniques such as HPLC, LC-MS, G.C., particle size analysis, and aerosol characterization.
• Excellent communication skills—written, verbal, and interpersonal.