Uniquity Bio

Director

• Lead analytical development and quality control activities supporting development, characterization, manufacturing, and regulatory approval of biopharmaceutical products
• Develop and implement robust analytical methods across the product development lifecycle
• Lead analytical method qualification, validation, and transfer for drug substance and drug product release and stability testing
• Oversee GMP and non-GMP stability studies
• Manage the reference standard lifecycle and two-tier reference standard system
• Review and approve QC raw data and analytical documentation packages
• Lead late-stage product characterization studies supporting CQA identification and product control strategy development
• Oversee drug substance and drug product comparability assessments
• Collaborate with internal teams, CMOs, and contract laboratories
• Maintain knowledge of GMP requirements, regulatory guidance, and industry best practices
• Author and review technical reports, analytical documentation, and CMC sections of global regulatory submissions
• Proactively identify and resolve technical and quality challenges
• Support analytical readiness for product commercialization
• Report to the Sr. Director, Analytical Development and Quality Control

Explore Associate Director, Analytical Development, Quality Control at Uniquity Bio. Review requirements and application details.

Associate Director, Analytical Development, Quality Control

General Counsel

• Provide legal services and support on a broad array of contract issues
• Draft, review, and negotiate vendor, clinical trial, manufacturing, commercial, confidentiality, and consulting agreements
• Support contracting for global clinical trials
• Identify risks in contract terms and develop practical risk-mitigation solutions
• Collaborate with legal and business teams to ensure contracts meet company needs
• Assist with administration and oversight of contract-related systems, structures, and processes
• Support the company’s contract management system
• Report to the Executive Director, Contracts and IP Counsel

Explore Director – Contracts Counsel at Uniquity Bio. Review requirements and application details.

Open roles

Associate Director, Analytical Development, Quality Control

Director – Contracts Counsel