Associate Director, Analytical Development & Quality Control

Position Overview Reporting to the Sr. Director, Analytical Development and Quality Control (AD & QC), the Associate Director AD & QC will lead analytical development and quality control activities to support the development, characterization, manufacturing, and regulatory approval of biopharmaceutical products. This individual will be responsible for establishing and maintaining robust analytical methods, overseeing method qualification, transfer, validation, and lifecycle management, and ensuring the successful execution of drug substance and drug product release and stability testing. The role will provide scientific and technical leadership across analytical development, QC, product characterization, comparability, and control strategy development, with a focus on advancing programs through late-stage development, process performance qualification (PPQ), and Biologics License Application (BLA) submission. The successful candidate will ensure analytical activities comply with applicable GMP requirements and global regulatory expectations while fostering strong collaboration across internal functions and external partners, including contract manufacturing organizations and contract laboratories. This individual will also contribute to CMC regulatory submissions, proactively identify and resolve technical and quality challenges, and help drive analytical readiness to support product commercialization. The role requires a strong scientific foundation in protein chemistry, analytical methods, and bioassays, along with demonstrated leadership, sound judgment, and the ability to influence cross-functional teams in a dynamic, fast-paced environment. Key Responsibilities Responsibilities include, but are not limited to: 34 Develop and implement robust, reliable analytical methods to support the product development lifecycle. 34 Lead analytical method qualification, validation, and transfer for drug substance (DS) and drug product (DP) release and stability testing. 34 Oversee GMP and non-GMP stability studies, ensuring scientifically sound study design, execution, and compliance with applicable quality standards and regulatory requirements. 34 Manage the reference standard lifecycle, including the establishment and maintenance of a two-tier reference standard system to support product registration and ongoing quality control. 34 Review and approve QC raw data and analytical documentation packages for release and stability testing, ensuring data integrity, accuracy, and compliance with GMP requirements. 34 Lead late-stage product characterization studies to support critical quality attribute (CQA) identification and the development of the product control strategy. 34 Oversee DS and DP comparability assessments to support process changes, continuous improvement, and product lifecycle management. 34 Collaborate closely with internal cross-functional teams and external partners, including contract manufacturing organizations (CMOs) and contract laboratories, to ensure timely and high-quality execution of analytical activities. 34 Maintain current knowledge of applicable GMP requirements, regulatory guidance, and industry best practices. 34 Author and review technical reports, analytical documentation, and Chemistry, Manufacturing, and Controls (CMC) sections of global regulatory submissions. Qualifications 34 Bachelors degree or higher (advanced degree preferred) in analytical chemistry, biochemistry, or a related scientific discipline, with at least 10 years of experience in the biopharmaceutical industry. 34 Strong scientific foundation in protein chemistry, analytical methods, and biological assays. 34 Significant experience in analytical development and/or quality control within the biopharmaceutical industry. 34 Demonstrated expertise in biologics analytical method development, qualification, transfer, validation, and lifecycle management, including an understanding of pharmaceutical and biopharmaceutical manufacturing processes. 34 Experience in late-stage monoclonal antibody (mAb) drug product development preferred. 34 Experience preparing and supporting analytical deliverables for process performance qualification (PPQ) and Biologics License Application (BLA) submissions preferred. 34 Experience with drug-device combination products preferred. 34 Experience managing analytical activities and deliverables with external partners, including CMOs and contract laboratories, preferred. 34 Ability and willingness to travel domestically and internationally to support external site oversight and management activities. 34 Demonstrated ability to influence stakeholders, build effective working relationships, and drive alignment across internal teams and external partners. 34 Excellent written and verbal communication skills, with the ability to clearly convey technical concepts, project objectives, and results. 34 Strong problem-solving, critical-thinking, and negotiation skills, with the ability to proactively identify risks, develop practical solutions, and achieve business objectives in a dynamic, cross-functional environment. Work Environment At Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment. This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon on a case-by-case basis with the employees manager. Business travel may be required depending upon the specific needs of the position. The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.