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Associate Director/Director of Analytical & GMP Quality Assurance Operations

On-site Full-time

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Experience Level

Senior Level Manager

Qualifications

The ideal candidate will possess a strong background in quality assurance, particularly within the biotechnology or pharmaceutical sectors. You should have proven experience in GMP compliance, analytical development, and quality control operations. Strong leadership skills, coupled with the ability to work collaboratively in a fast-paced environment, are essential. A degree in a scientific discipline, along with relevant certifications, is preferred.

About the job

At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the development of potentially groundbreaking treatments, whether as standalone interventions or in combination therapies targeting various solid tumors. For more insights into our mission and vision, visit our website and connect with us on LinkedIn and X.

We are currently in search of an Associate Director or Director of Analytical & GMP Quality Assurance Operations. In this pivotal role, you will oversee and guide the QA functions related to analytical development, quality control operations, and GMP quality activities across our clinical-stage biologics and ADC programs. Collaboration with cross-functional teams, including CMC, Analytical Sciences, Quality Control, and Technical Operations, as well as external manufacturing and testing partners, will be key to ensuring compliance with phase-appropriate GMP standards, maintaining data integrity, and ensuring inspection readiness within a dynamic outsourced operational framework. Your strategic vision will be instrumental in shaping Crescent's analytical quality strategy and driving the disciplined execution of core quality systems that align with our aggressive development timelines.

About Crescent Biopharma

Crescent Biopharma is dedicated to advancing oncology treatments through innovative and effective therapies, with a commitment to improving the lives of cancer patients globally.

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