Associate Director, Analytical Development

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Provide scientific and operational guidance for analytical development across biologics programs from early development through late-stage and commercialization, primarily collaborating with external partners.

• Lead the analytical strategies for potency, impurities, and other release assays that support biologics development, clinical supply, late-stage development, and readiness for commercialization.

• Analyze and apply product quality data to establish Critical Quality Attributes (CQAs), Quality Target Product Profiles (QTPPs), control strategies, and characterization packages that support regulatory submissions and process modifications.

• Oversee the development, qualification, and testing activities of analytical methods at Contract Development and Manufacturing Organizations (CDMOs) and contract test laboratories.

• Create and review analytical reports, technical summaries, and various product development documents.

• Draft and review the analytical sections of Chemistry, Manufacturing, and Controls (CMC) regulatory submissions while effectively communicating analytical risks, timelines, and data interpretations.

• Establish and nurture relationships with CDMO and contract test laboratory partners, utilizing metrics to manage risk, prioritize tasks, and promote continuous improvement.

• Stay updated on evolving CMC and global regulatory strategies for biologics and small-molecule programs.

• Provide mentorship, coaching, and leadership to both internal and matrixed teams.

• Collaborate with Quality Control (QC) and Quality stakeholders on method validations, method transfers, reference material qualifications, investigations of deviations and Out of Specification (OOS)/Out of Trend (OOT) results, CAPA activities, and lifecycle management.

• Perform other assigned duties.

⛳️ Requirements

• PhD in Chemistry, Biochemistry, or a related discipline with 8–12 years of experience in analytical development and Quality Control (QC) supporting biologics programs from preclinical to late-stage development.

• BS/MS with 10–12 years of relevant industry experience in analytical laboratories supporting biologics development and manufacturing.

• Strong technical knowledge in biologics analytical sciences, including potency and impurities assays, life-cycle management methods, and data interpretation.

• Proven experience in supporting regulatory submissions and collaborating with Quality and Regulatory functions.

• Demonstrated ability to manage external partners and achieve results in a dynamic biotech environment.

• Excellent written and verbal communication skills, with experience in authoring technical reports and regulatory documents.

• Required experience in method development, validation, transfer, and GMP release and stability testing of biologics, including potency and impurities assays.

🏝️ Benefits

• Commitment to equal employment opportunities.

• Employer status as a protected entity for Veterans and Individuals with Disabilities.