Director, Analytical Development — Late-Stage Biologics

Avalo Therapeutics, Inc.; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Avalo Therapeutics is seeking a Director, Analytical Development in a hybrid role based at its Chesterbrook, PA location. You will provide strategic leadership for analytical development across clinical to commercial stages, partnering with external laboratories and CDMOs to ensure robust, compliant methods and specifications.

You will guide method development, transfer, qualification, and lifecycle management while shaping strategy for stability, comparability, and regulatory submissions to

Qualifications

• Ph.D., M.S., or B.S. in Analytical Chemistry, Biochemistry, Chemistry, Pharmaceutical Sciences, Biotechnology, Biology, or a related field.
• 10+ years of progressive biopharmaceutical industry experience in analytical development, characterization, Quality Control, and/or CMC development.
• Demonstrated experience supporting late-stage biologics development, including Phase 3 programs and progression toward regulatory filing and commercial readiness.
• Significant experience developing and implementing analytical strategies for biologic drug substance and/or drug product.
• Experience with monoclonal antibodies, recombinant proteins, or other biologic products.
• Demonstrated experience with analytical method development, qualification, validation, transfer, and lifecycle management.

Responsibilities

• Provide technical leadership for analytical development activities supporting all phases of clinical development and progression toward commercial manufacturing.
• Develop and execute analytical strategies generating and implementing new specifications, supporting clinical supply, process characterization, PPQ/process validation, regulatory submissions, and commercial launch.
• Lead development and implementation of phase-appropriate analytical control strategies for biologic drug substance and drug product.
• Drive analytical method development, optimization, qualification, validation, transfer, and lifecycle management.
• Ensure analytical methods are appropriate for their intended use and capable of supporting product release, stability, characterization, comparability, and process validation activities.
• Partner with Quality and Regulatory CMC to establish and justify appropriate specifications for drug substance, drug product, intermediates, and other relevant materials.
• Provide analytical leadership supporting PPQ and commercial readiness activities.

Skills

Analytical leadership

Biologics

Regulatory knowledge

CRO/CDMO management

Process development

Education

Ph.D./M.S./B.S. in Analytical Chemistry or related

Tools

HPLC/UPLC

SEC

CIEF

Mass spectrometry

Job description

Avalo Therapeutics is seeking a Director, Analytical Development in a hybrid role based at its Chesterbrook, PA location. You will provide strategic leadership for analytical development across clinical to commercial stages, partnering with external laboratories and CDMOs to ensure robust, compliant methods and specifications.

You will guide method development, transfer, qualification, and lifecycle management while shaping strategy for stability, comparability, and regulatory submissions to