Remotely
quality controlanalytical developmentvalidationgmpcdmobiologicsmethod transferstability
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Job Description
📋 Description
- Lead strategic direction and execution of analytical development and quality control for biologics
- Define long-term strategy, governance, and external partner network for biologics analytics from
- Oversee phase-appropriate control strategies, including method development, qualification
- Represent analytical/QC to CDMO, contract labs, and cross-functional teams; ensure inspection
- Build and lead a high-performing analytical organization; manage budget, resources, and external
- Drive technology adoption, KPI governance, and continuous improvement across analytical operations.
🎯 Requirements
- Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field with 15+
- Deep expertise in analytical development and QC for biologics (antibodies, fusion proteins, complex
- Proven track record delivering analytical strategies from lead candidate to commercialization
- Extensive experience with method development/transfer/validation, specifications, comparability
- Strong leadership in outsourced models with CDMOs and external labs; GMP, data integrity, and
- Excellent communication, cross-functional leadership, and strategic business acumen.
🎁 Benefits
- Competitive base salary with annual bonus eligibility and equity compensation.
- Comprehensive benefits package.
- Opportunity to influence late-stage development and global regulatory readiness.
- Collaborative, cross-functional environment with external partners.
