Associate Director, Analytical Sciences, Attribute Characterization

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the structural and functional characterization along with comparability studies for Spyre’s clinical and late-stage mAb and mAb-mAb combination initiatives.

• Offer strategic and technical direction for multidimensional biologics characterization to enhance product understanding and comparability in a phase-appropriate manner.

• Act as a subject matter expert (SME) in the molecular characterization and comparability of mAb and mAb-mAb combination products.

• Assist in the development of analytical control strategies and regulatory documentation.

• Lead comparability and characterization efforts at contract development and manufacturing organizations (CDMOs).

• Ensure that analytical activities comply with scientific, regulatory, and industry standards.

• Formulate characterization strategies in partnership with analytical SMEs.

• Support ADQC activities, which include method development, investigations, and review of quality control release and stability data.

• Establish best practices and protocols for assessing structure–function relationships and critical quality attributes (CQA).

⛳️ Requirements

• Possess an advanced degree in Mass Spectrometry, Biophysical Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field, along with over 8 years of experience in the biopharma industry focusing on biologics analytical, formulation, or process development.

• Proven track record supporting regulatory submissions (IND, CTA, BLA), with significant expertise in phase-appropriate characterization and comparability studies, as well as related analytical techniques.

• Demonstrated leadership abilities and strong communication skills, capable of managing biologics program deliverables in a dynamic environment; experience with mAb combination products is preferred, and familiarity with device testing is a plus.

• Experience in utilizing artificial intelligence (AI) and machine learning (ML) to improve analytical efficiency, automate attribute trending, and aid in knowledge generation and decision-making.

🏝️ Benefits

• Competitive market compensation and benefits package, which includes a base salary, performance bonuses, equity grant opportunities, along with health, welfare, and retirement benefits.

• Unlimited paid time off (PTO).

• Two one-week company-wide shutdowns annually.

• A commitment to providing professional development opportunities.

• A remote working environment complemented by frequent in-person meetings to tackle complex challenges and foster relationships.