Associate Director, Analytical Development

The Associate Director, Analytical Development will be responsible for key aspects of pharmaceutical development. A key role will be the regulatory authoring and creating a robust BLA submission.

You will focus on late stage product development and the biologic / device combination product, inclusive of the data and studies associated with the development or optimization of analytical methods, product characterization of a lipid-peptide formulation, aerosol characterization of the combination product, and management of drug substance/drug product stability studies supporting clinical and BLA registration.

• What are the key responsibilities?Regulatory Authoring and Quality Compliance: Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to cGMP and regulatory requirements.
• Leadership & Strategy: Manage analytical development projects for biologics, proteins, and peptides, managing projects executed at CDMOs / Contract Laboratories and the data they generate. Develop and execute strategies aligned with company mission and regulatory standards.
• Analytical Methods: Manage method optimization, validation, and transfer for procedures controlling the quality of lipids, proteins, and peptides. Experience with protein and lipid analytical characterization is prefered. Ensure methods are robust and comply with industry standards.
• Stability Management: Design and manage stability studies determining retest date / shelf life of products for late stage clinical development, and primary stability studies defining commercial shelf life for BLA.
• Product Characterization: Design and manage the execution of late stage product characterization studies supporting BLA filing at Contract Laboratories.
• 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.
• 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 complex analytical issues during development. Implement corrective and preventive actions as needed.
• What education and experience are required?
• Late-stage product development experience is required.
• Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is required.
• Bachelors or Masters Analytical Chemistry, Chemistry, Biochemistry, or related field.
• 5-10 years of product development experience.
• Experience managing CDMOs / Contract Laboratories is required.
• Knowledge of Good Manufacturing Practices is required.
• Experience with sterile manufacturing is a plus.
• Experience with lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus.
• Knowledge and experience in drug-device development, and inhalation drug delivery including aerosol characterization techniques is a plus.
• What key skills will make you great at the role?
• Communication : Strong written and oral communications skills
• Stability Management: Experience managing stability programs supporting clinical shelf life and primary stability studies for NDA/BLAs.
• Regulatory Knowledge: Deep understanding of regulatory requirements and submission processes for IND and BLA.
• Technical Expertise: Proficiency in lipid and protein quantitation and characterization techniques (e.g. HPLC, LCMS, GCMS). Experience with physical characterization techniques (e.g. Viscosity, Particle Size) and/or aerosol characterization techniques (DDU, aPSD).
• Problem-Solving: Strong analytical skills with a proven track record of overcoming complex scientific challenges. Experience in managing OOS results and analytical investigations.
• Results oriented: Strong initiative, accountability and willingness to take ownership and drive projects to completion. Work independently with CDMOs / Contract Laboratories without close supervision.