Associate Director, Analytical Sciences and Attribute Characterization
New
S
Spyre TherapeuticsBiotechnology
US- RemoteFull-TimeManager
Salary175,000 - 190,000 USD per year
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Job Details
- Experience
- 8+ years
- Required Skills
- Artificial IntelligenceMachine Learning
Requirements
- Advanced degree in Mass spectrometry, Biophysical chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or a related discipline.
- 8+ years of biopharma industry experience in biologics analytical, formulation or process development.
- Demonstrated experience supporting regulatory submissions (IND, CTA, BLA).
- Expertise in phase-appropriate characterization and comparability studies.
- Proven leadership and communication skills.
- Experience leveraging artificial intelligence (AI) and machine learning (ML) to enhance analytical efficiency.
- Experience with mAb combination products preferred.
- Experience with device testing is an advantage.
Responsibilities
- Provide strategic and technical leadership for multidimensional biologics characterization.
- Serve as subject matter expert (SME) in mAb and mAb-mAb combination product molecular characterization.
- Contribute to analytical control strategies and regulatory content development.
- Lead comparability and characterization activities at CDMOs.
- Ensure analytical activities meet scientific, regulatory (FDA, EMA, ICH), and industry standards.
- Develop characterization strategies in collaboration with analytical SMEs.
- Partner with process (DS, DP, device) and regulatory teams.
- Support ADQC activities, including method development and investigations.
- Establish best practices for structure–function relationships, PTM analysis, and CQA assessment.
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