Associate Director, Analytical Development – Inhalation (Remote)

Triwill Group; United States; On-site; USD 180,000 - 205,000; Full time

Benefits offered by this job

Remote work within the United States

Competitive base salary $180,000–$205,

Job summary

Partner Company seeks an Associate Director, Analytical Development to lead strategy across drug substances and inhalation products, from method development to lifecycle management. You will drive late-stage characterization, PPQ, and regulatory readiness while partnering with QA, Regulatory, Manufacturing, and external CDMOs.

The role demands advanced scientific education with 8+ years in analytical development, strong cGMP experience, and proven cross-functional leadership to drive

Qualifications

• Advanced scientific education, ideally a Ph.D. in Analytical Chemistry or related field.
• 8+ years of analytical development experience in biotech/pharma.
• Strong late‑stage and cGMP experience across development to commercialization.
• Expertise in method development, validation, and transfer.
• Inhalation drug development knowledge is highly desirable.
• Regulatory and CMC experience with FDA/EMA expectations.
• Experience managing external partners (CDMOs, labs).
• Ability to translate complex data into development and regulatory decisions.
• Willingness to travel ~10%.

Responsibilities

• Lead analytical development strategy for drug substances and inhalation products.
• Drive late-stage inhalation characterization of CQAs.
• Develop product control strategies connecting methods, specs, and stability.
• Support comparability and bridging during process/formulation/device changes.
• Lead validation and transfer activities to contract labs and manufacturers.
• Provide analytical leadership for PPQ and commercial readiness.
• Support regulatory submissions with analytical sections.
• Oversee CDMOs and external labs; review protocols and investigations.
• Collaborate with QA, Regulatory, Product Development, and Manufacturing.
• Identify opportunities to improve workflows, docs, and scalability.
• Support regulatory inspections and health authority interactions.

Skills

Analytical leadership

Cross-functional leadership

Analytical method development

Regulatory readiness

Project management

Communication skills

Travel readiness

Education

PhD in Analytical Chemistry

MS with industry experience

Job description

Partner Company seeks an Associate Director, Analytical Development to lead strategy across drug substances and inhalation products, from method development to lifecycle management. You will drive late-stage characterization, PPQ, and regulatory readiness while partnering with QA, Regulatory, Manufacturing, and external CDMOs.

The role demands advanced scientific education with 8+ years in analytical development, strong cGMP experience, and proven cross-functional leadership to drive