Associate Director, Quality Control

About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

The Associate Director/Director of QC will be a key leader within the TechOps QC/Analytical team, providing critical technical and authoring expertise to support the quality control and analytical aspects of our product lifecycle. This role will leverage technical and authoring expertise in quality control and analytical sciences, with a primary focus on strategic topics such as comparability, stability, raw materials, and reference standards. The individual will play a critical part in both authoring and reviewing technical documents to support clinical and commercial products.

Location: Remote

Essential Functions

• Function as an internal expert in reference standard, raw materials, stability, comparability and analytical test methods used for release and characterization of an oncolytic Adenovirus intended for human use.
• Manage implementation and changes in reference standards and ongoing and new stability studies to meet strategic and operational needs.
• Review and approve assay development and validation reports, relevant sections of submission documents pertaining to Adenovirus analytical testing and documentation for submission to regulatory agencies.
• Author IND, BLA, NDA, sections pertaining to raw materials, analytical comparability, stability and reference standards.
• Support strategy development for content provided to regulatory agencies, author, review and approve QC related content
• Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
• Engage in various strategic discussions both internally and externally on QC and analytical related topics.
• Provides clear and concise communications and instructions to internal and external stakeholders to support manufacturing activities related to clinical and commercial products.
• Ability to troubleshoot operational and scientific questions, maintaining direction to a final solution.
• Ensure that CMC documentation is complete, well organized, scientifically sound, of a high quality, aligned with the current regulations, and presented in a manner that facilitates Health Authority reviews.
• Advise manufacturing, Quality and supply chain on management of reference standards and plan accordingly to support ongoing and anticipated activities.
• Ensure quality control system for assigned responsibilities is aligned with and meets quality expectations and the industry regulations.
• Strong planning and resource management skills in a dynamic project environment located across multiple geographies.
• Self-directed individual who can manage work with limited direction in a fast-paced, goal-oriented environment.
• Knowledgeable in cGMP, FDA, USP, regulations and guidelines related to the manufacture and testing of Gene therapy products.

Qualifications

• BSc or MSc in chemistry, pharmaceutical sciences or related discipline
• 8+ years of experience in the biotechnology industry.
• Self-directed individual who can manage work with limited direction in a fast-paced, goal-oriented environment.
• Experience working with drug substance and/or drug product CMOs and participating in cross functional and virtual teams.
• Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to complete assignments on-time, experience with the principals of operational excellence.