Associate Director, Analytical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the analytical strategy for the development and commercial readiness of late-stage drug substances and inhalation drug products.

• Oversee the development, optimization, qualification, validation, transfer, and lifecycle management of analytical methods.

• Design and spearhead the characterization of critical quality attributes for inhalation products.

• Formulate inhalation product control strategies that connect methods, specifications, stability, in-use conditions, and device performance.

• Facilitate comparability and bridging assessments for changes in processes, formulations, devices, and suppliers.

• Create and authorize validation protocols and reports.

• Address analytical issues that arise during validation and commercial manufacturing processes.

• Ensure analytical readiness and act as the analytical lead for PPQ batches at CDMO vendors.

• Evaluate sampling plans, acceptance criteria, and data packages for clinical, PPQ, and commercial release.

• Provide technical oversight for method transfers to contract laboratories and manufacturing partners.

• Draft and review analytical sections of INDs, IMPDs, CTAs, NDA/BLA Module 3 documents, annual reports, and regulatory responses.

• Assist with Health Authority inspections and information requests.

• Supervise cGMP analytical activities conducted by external laboratories and CDMOs.

• Review protocols, reports, investigations, deviations, OOS/OOT results, and change controls.

• Collaborate with Product Development, Quality Assurance, Regulatory Affairs, Technical Operations, Manufacturing, Program Management, and other stakeholders.

• Offer analytical expertise for process development, stability, specifications, comparability, and lifecycle management.

• Enhance analytical workflows, documentation, laboratory efficiency, and scalable analytical systems.

⛳️ Requirements

• A Ph.D. or equivalent degree is preferred; a Master's degree with substantial industry experience is also acceptable.

• A minimum of 8 years of analytical development experience in supporting drug substances and inhalation solution drug products is essential.

• Experience in inhalation drug development is desirable and highly valued.

• Significant experience in supporting cGMP late-stage development and commercial manufacturing for inhalation products is required.

• Proficient in analytical method development, validation, and transfer for compendial and aerosol methodologies.

• Experience in supporting PPQ campaigns and activities related to commercial readiness.

• Strong knowledge of inhalation devices and aerosol characterization is preferred.

• Capability to oversee external CDMOs and contract laboratories.

• Expertise in developing and authoring regulatory and CMC documentation.

• Experience in assisting FDA, EMA, and/or global regulatory inspections is preferred.

• Technical proficiency in analytical chemistry, inhalation development, and late-stage commercialization is preferred.

• Ability to work independently within a small biotech environment while managing multiple CDMOs and external partners.

• Cross-functional leadership skills and the ability to influence without direct authority.

• Willingness and ability to travel 10% of the time is required.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and advancement.

• Flexible work arrangements to promote work-life balance.