Associate Director, Analytical Development

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

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Analytical Development based in United States.

This is a strategic, hands-on leadership role supporting the late-stage development and commercialization of innovative inhaled therapies for serious respiratory diseases.
This will own the analytical strategy across drug substance and inhalation drug products, from method development through validation, transfer, and lifecycle management.
The role will directly support Phase 3 clinical programs, PPQ campaigns, regulatory submissions, and future commercial manufacturing.
You will provide technical leadership across complex inhalation analytical challenges, including aerosol performance, critical quality attributes, stability, and comparability.
Working in a collaborative biotech environment, you will partner closely with Quality, Regulatory, Manufacturing, Product Development, and external CDMO organizations.
The position offers significant influence over analytical standards, regulatory readiness, and scalable systems as programs progress toward commercialization.
It is an opportunity to combine deep scientific expertise with cross-functional leadership and meaningful impact on the development of potentially transformative respiratory medicines.

Accountabilities:

• Lead analytical development strategy for drug substances and inhalation drug products, including analytical method development, optimization, qualification, validation, transfer, and lifecycle management.
• Drive late-stage inhalation characterization of critical quality attributes, including delivered dose, aerodynamic particle size distribution, fine particle dose and fraction, nebulization performance, residual volume, aerosol output, droplet and particle size, pH, osmolality, viscosity, impurities, and degradation pathways.
• Develop product control strategies that connect analytical methods, specifications, stability programs, in‑use conditions, device performance, and clinically relevant product quality attributes.
• Support comparability and bridging activities associated with changes to processes, formulations, devices, suppliers, and other components throughout development and commercialization.
• Lead analytical validation and transfer activities, including protocol and report development, troubleshooting, acceptance criteria, sampling plans, data‑package review, and technical oversight of transfers to contract laboratories and manufacturing partners.
• Provide analytical leadership for PPQ and commercial readiness, supporting PPQ batches, analytical readiness strategies, commercial release requirements, and manufacturing‑related analytical issues.
• Support CMC regulatory activities by authoring and reviewing analytical sections of regulatory submissions, including clinical and marketing applications, Module 3 documentation, annual reports, and responses to regulatory questions.
• Provide technical oversight of CDMOs and external laboratories, reviewing protocols, reports, investigations, deviations, OOS/OOT results, change controls, and other cGMP analytical deliverables.
• Collaborate across functions including Quality Assurance, Regulatory Affairs, Product Development, Technical Operations, Manufacturing, Clinical, and Program Management to ensure analytical activities support broader development objectives.
• Strengthen analytical systems and processes by identifying opportunities to improve workflows, documentation, laboratory efficiency, scalability, and commercialization readiness.
• Support regulatory inspections and health authority interactions, providing analytical expertise and responding to technical requests as needed.

Requirements:

• Advanced scientific education, ideally a Ph.D. or equivalent in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline; a Master's degree combined with substantial relevant industry experience may also be considered.
• 8+ years of analytical development experience in biotechnology, pharmaceutical, or a related industry, with experience supporting drug substances and inhalation solution drug products.
• Strong late‑stage and cGMP experience, including analytical support for clinical development, commercial manufacturing, PPQ campaigns, and commercialization readiness.
• Demonstrated expertise in analytical method development, validation, and transfer, including compendial methods and aerosol‑specific analytical methodologies.
• Inhalation drug development experience is highly desirable, particularly knowledge of inhalation devices, aerosol characterization, and performance testing.
• Strong analytical chemistry expertise with the ability to translate complex technical data into practical development and commercialization decisions.
• Regulatory and CMC experience, including authoring or reviewing technical documentation and familiarity with FDA, EMA, and/or other global regulatory expectations and inspections.
• Experience managing external partners, with the ability to provide scientific and technical oversight to CDMOs and contract laboratories while maintaining quality and delivery standards.
• Strong understanding of regulatory expectations and relevant analytical guidance, including ICH, USP, FDA, EMA, and applicable global requirements.
• Strategic and cross‑functional leadership skills, with the ability to influence decisions without direct authority and align technical priorities with development timelines.
• Strong project management and organizational abilities, including the capacity to manage multiple external partners and complex priorities simultaneously.
• Independent and adaptable working style, with the ability to thrive in a small, fast‑moving biotech environment while maintaining scientific rigor and attention to detail.
• Excellent communication and collaboration skills, particularly when working across scientific, quality, regulatory, manufacturing, and external partner teams.
• Willingness and ability to travel approximately 10% as required.

Benefits:

• Competitive base salary: approximately $180,000–$205,000 USD annually, based on the stated compensation range.
• Remote work within the United States.
• Opportunity to contribute to late‑stage development and commercialization of innovative inhaled therapies for serious and rare respiratory diseases.
• Significant scientific and strategic ownership across analytical development, regulatory readiness, PPQ, and commercial manufacturing.
• Close collaboration with multidisciplinary internal teams and external CDMO and laboratory partners.
• Opportunity to work in a dynamic biotech environment with meaningful influence over analytical strategy and commercialization systems.
• Professional growth through exposure to advanced inhalation technologies, regulatory activities, global development programs, cross‑functional leadership.