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Analytical Development Jobs (NOW HIRING)

Evommune

$200 - $250/hr

Associate Director/ Director, Analytical Development, Biologics About Evommune, Inc. Evommune, Inc. (NYSE: EVMN) is a clinical-stage biotechnology company focused on developing innovative therapies ...

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How much do analytical development jobs pay per year?

As of Sep 9, 2026, the average yearly pay for analytical development in the United States is $74,986.00, according to ZipRecruiter salary data. Most workers in this role earn between $53,000.00 and $93,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Analytical Development?

To thrive in Analytical Development, you need a solid background in chemistry, biochemistry, or a related field, often supported by a relevant degree and experience in analytical methodologies. Familiarity with laboratory instruments such as HPLC, GC, and mass spectrometry, as well as knowledge of regulatory guidelines like ICH and GMP, is essential. Strong problem-solving skills, attention to detail, and effective communication set standout professionals apart in this role. These skills ensure the accurate development, validation, and transfer of analytical methods critical for product quality and regulatory compliance.

What are some common challenges faced in an Analytical Development role, and how can job seekers prepare for them?

Professionals in Analytical Development often encounter challenges such as developing robust methods for complex samples, meeting tight project deadlines, and ensuring regulatory compliance. To prepare, job seekers should build strong problem-solving skills, gain familiarity with a range of analytical techniques (such as HPLC, GC, and spectroscopy), and stay current with industry regulations like ICH guidelines. Collaborating effectively with cross-functional teams, such as Quality Control and Research & Development, is also essential for success in this role.

What is the difference between Analytical Development vs Quality Control Analyst?

AspectAnalytical DevelopmentQuality Control Analyst
Primary FocusDeveloping and optimizing analytical methods for new productsPerforming routine testing to ensure product quality
Work EnvironmentLaboratories involved in method development and validationQuality control labs conducting batch testing and release
Required CredentialsBachelor's or higher in Chemistry, Biochemistry, or related fields; experience in method developmentBachelor's in Chemistry, Biology, or related fields; experience in testing procedures

Analytical Development professionals focus on creating and refining analytical methods for new products, while Quality Control Analysts perform routine testing to verify product quality. Both roles require similar educational backgrounds and work in laboratory settings, but their responsibilities differ in scope and purpose.

What is analytical development?

Analytical development is a field within pharmaceutical and biotech industries focused on creating and validating methods to analyze the quality, purity, and stability of drug substances and products. It involves developing techniques such as chromatography and spectroscopy, often requiring knowledge of regulatory standards and laboratory skills. Professionals in this area support drug development by ensuring analytical methods are reliable and compliant with industry regulations.

What is the job description of analytical development?

Analytical development involves designing, optimizing, and validating analytical methods to measure the quality and stability of pharmaceutical or chemical products. Professionals in this field use techniques such as chromatography, spectroscopy, and other laboratory tools, often working in regulated environments that require compliance with industry standards and documentation practices.
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Analytical Development jobs near you
Infographic showing various Analytical Development job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 86% Physical, 3% Hybrid, and 11% Remote job distribution, with an average salary of $74,986 per year, or $36.1 per hour.

Associate Director, Analytical Development

Remote

Avalyn Pharma
Biotechnology Research and Development • 1 - 10 employees
Learn more about Avalyn Pharmaexternal

Full-time

Posted 29 days ago

Job description

About Avalyn
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn's AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn's AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA-IPF, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.
Position Overview:
Reporting to the Director, Product Development, the Associate Director, Analytical Development is responsible for leading the analytical strategy supporting Avalyn's late-stage drug substance and inhalation drug product development and commercial readiness activities. This individual will provide technical leadership for analytical method development, validation, transfer, and lifecycle management to support ongoing Phase 3 inhalation clinical studies, Process Performance Qualification (PPQ) batches, regulatory submissions, and future commercial manufacturing activities. The position works closely with internal cross-functional teams, including Quality, Regulatory Affairs, and Clinical, as well as external CDMO partners, to lead and oversee analytical activities in alignment with the highest scientific, quality, and regulatory standards.
Key Responsibilities:
Analytical Development
  • Lead development, optimization, qualification, validation, and lifecycle management of analytical methods to support Avalyn's drug substances and inhalation drug products.
  • Design and lead late-stage characterization of inhalation critical quality attributes, including delivered dose, aerodynamic particle size distribution, fine particle dose/fraction, nebulization performance, residual volume, aerosol output rate, droplet/particle size, pH, osmolality, viscosity, impurities, and degradation pathways.
  • Develop late-stage inhalation product control strategies that link analytical methods, specifications, stability programs, in-use conditions, and device performance to clinically relevant product quality attributes.
  • Define and support E/L control strategies aligned with applicable regulatory guidances.
  • Support inhalation product comparability and bridging assessments for process, formulation, device, or supplier changes across development and commercialization.
  • Define acceptance criteria needed to support regulatory expectations for inhalation medicinal products, including pharmaceutical development rationale, device compatibility, performance characterization, and lifecycle management.

Method Validation
  • Develop and approve validation protocols and reports.
  • Ensure validation activities comply with ICH Q2, USP, FDA, EMA, and applicable global regulatory expectations.
  • Resolve analytical issues arising during validation and commercial manufacturing.
  • Partner closely with internal teams to develop analytical readiness strategies for successful PPQ execution.
  • Serve as the analytical lead supporting PPQ batches manufactured at Avalyn's CDMO vendors.
  • Review analytical sampling plans, acceptance criteria and data packages supporting clinical, PPQ and commercial release.
  • Provide technical oversight for method transfers to contract laboratories and manufacturing partners.

CMC Regulatory Support
  • Author and review analytical sections of regulatory submissions, including INDs, IMPDs, CTAs, NDA/BLA Module 3 documentation, annual reports, regulatory responses, and related documents
  • Support Health Authority inspections and information requests.

CDMO Management
  • Provide scientific oversight of cGMP analytical activities performed by external laboratories and CDMO vendors.
  • Review protocols, reports, investigations, deviations, OOS/OOT results, and change controls.
  • Ensure vendors meet Avalyn quality and technical expectations.

Cross-Functional Collaboration
  • Partner with cross-functional teams, including Product Development, Quality Assurance, Regulatory Affairs, Technical Operations, Manufacturing, Program Management, and other internal stakeholders
  • Provide analytical expertise supporting process development, stability, specifications, comparability, and lifecycle management.

Continuous Improvement
  • Identify opportunities to improve analytical workflows, documentation, and laboratory efficiency.
  • Develop scalable analytical systems to support Avalyn's transition toward commercialization.

Qualifications:
  • Ph.D. (or equivalent degree) in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related scientific discipline preferred.
  • Master's degree with significant industry experience will also be considered.
  • 8+ years of analytical development experience supporting drug substances and inhalation solution drug products in the biotech/pharma or related industry is required.
  • Experience with inhalation drug development is desirable and will be given high consideration.
  • Strong experience supporting cGMP late-stage development and commercial manufacturing supporting inhalation products.
  • Demonstrated experience with analytical method development, validation, and transfer supporting compendial and aerosol methodologies.
  • Demonstrated success supporting PPQ campaigns and commercial readiness activities.
  • Strong knowledge of inhalation devices and aerosol characterization preferred.
  • Proven ability to effectively oversee external CDMOs and contract laboratories.
  • Expertise in developing and authoring regulatory and CMC documentation.
  • Experience supporting FDA, EMA, and/or global regulatory inspections preferred.
  • Deep technical expertise in analytical chemistry, with an emphasis on inhalation development and late-stage commercialization is preferred
  • Ability to work independently in a small biotech environment while effectively managing multiple CDMOs and external partners.
  • Strong cross-functional leadership and ability to influence without direct authority, while balancing technical detail with strategic development timelines.
  • Willingness and ability to travel 10% is required

Proposed pay range
$180,000-$205,000 USD

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