Associate Director, Inhalation Analytical Development

Avalyn Pharma

United States

Hybrid

USD 180,000 - 240,000

Full time

14 days+

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Benefits offered by this job

401(k) match

Remote work options

Tuition reimbursement

Bonus program

Job summary

Avalyn Pharma is seeking an Associate Director of Analytical Development to lead the analytical strategy for late-stage drug substances and inhalation products. You will guide method development, validation, transfer, and lifecycle management for regulatory submissions and commercial readiness, partnering with Quality, Regulatory Affairs, and Clinical teams.

The role requires 8+ years in analytical development, strong cGMP experience in inhalation, and proven cross-functional leadership.

Qualifications

Ph.D. (or equivalent) in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related field preferred.
8+ years of analytical development experience in biotech/pharma, especially inhalation products.
Experience with cGMP late-stage development and commercial manufacturing for inhalation products.
Expertise in analytical method development, validation, and transfer for regulatory filings.

Responsibilities

Lead development, validation, transfer, and lifecycle management of analytical methods for drug substances and inhalation products.
Characterize inhalation attributes: delivered dose, particle size, nebulization performance, and related QC attributes.
Define acceptance criteria and regulatory strategies for inhalation products; support PPQ and regulatory submissions.