Associate Director, Analytical Development & Quality Control

Uniquity Bio Inc. • Malvern, PA

9h

About The Position

The Associate Director, Analytical Development & Quality Control (AD & QC) leads analytical development and quality control activities supporting the development, characterization, manufacturing, and regulatory approval of biopharmaceutical products. Reporting to the Sr. Director, Analytical Development and Quality Control, this role establishes and maintains robust analytical methods and oversees their qualification, transfer, validation, and lifecycle management, as well as drug substance and drug product release and stability testing.

The position provides scientific and technical leadership across analytical development, QC, product characterization, comparability, and control strategy development, with an emphasis on late-stage development, process performance qualification (PPQ), and Biologics License Application (BLA) submission. The role ensures analytical work meets applicable GMP requirements and global regulatory expectations, contributes to CMC regulatory submissions, and supports analytical readiness for commercialization.

The Associate Director collaborates with internal functions and external partners, including contract manufacturing organizations and contract laboratories, to resolve technical and quality challenges and deliver analytical activities. The position calls for a strong foundation in protein chemistry, analytical methods, and bioassays, along with leadership, sound judgment, and the ability to influence cross-functional teams.

This is a U.S.-based role. Team members living within commuting distance of the Malvern, PA or San Diego, CA offices are expected to spend time in the office; remote employees are expected to travel to an office regularly. Specific arrangements are agreed upon with the employee’s manager. Business travel may be required, and the role may involve domestic and international travel to support external-site oversight and management.

Requirements

• Bachelor's degree or higher in analytical chemistry, biochemistry, or a related scientific discipline; an advanced degree is preferred.
• At least 10 years of experience in the biopharmaceutical industry.
• Strong scientific foundation in protein chemistry, analytical methods, and biological assays.
• Significant experience in analytical development and/or quality control within the biopharmaceutical industry.
• Expertise in biologics analytical method development, qualification, transfer, validation, and lifecycle management.
• Understanding of pharmaceutical and biopharmaceutical manufacturing processes.
• Ability and willingness to travel domestically and internationally to support external-site oversight and management.
• Ability to influence stakeholders, build effective working relationships, and drive alignment across internal teams and external partners.
• Excellent written and verbal communication skills, including the ability to convey technical concepts, project objectives, and results clearly.
• Strong problem-solving, critical-thinking, and negotiation skills, with the ability to identify risks, develop practical solutions, and achieve business objectives in a dynamic, cross-functional environment.
• Ability to work independently and collaboratively in a complex, fast-paced environment.

Nice To Haves

• Experience in late-stage monoclonal antibody drug product development.
• Experience preparing and supporting analytical deliverables for PPQ and BLA submissions.
• Experience with drug-device combination products.
• Experience managing analytical activities and deliverables with external partners, including CMOs and contract laboratories.
• An advanced degree in analytical chemistry, biochemistry, or a related scientific discipline.

Responsibilities

• Develop and implement robust, reliable analytical methods to support 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, including study design and execution, ensuring compliance with applicable quality standards and regulatory requirements.
• Manage the reference standard lifecycle, including establishing and maintaining a two-tier reference standard system for product registration and ongoing quality control.
• Review and approve QC raw data and analytical documentation packages for release and stability testing, ensuring data integrity, accuracy, and GMP compliance.
• Lead late-stage product characterization studies to support critical quality attribute identification and product control strategy development.
• Oversee drug substance and drug product comparability assessments supporting process changes, continuous improvement, and product lifecycle management.
• Collaborate with internal cross-functional teams and external partners, including CMOs and contract laboratories, to ensure timely, high-quality execution of analytical activities.
• Maintain current knowledge of applicable GMP requirements, regulatory guidance, and industry best practices.
• Author and review technical reports, analytical documentation, and CMC sections of global regulatory submissions.
• Contribute to analytical readiness for commercialization and help identify and resolve technical and quality challenges.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior